Co-Diagnostics（C970）株式概要コ・ダイアグノスティックス社は、核酸分子の検出や分析を通じて機能する診断検査に使用される試薬の開発、製造、販売を米国内外で行う分子診断薬会社である。 詳細C970 ファンダメンタル分析スノーフレーク・スコア評価2/6将来の成長2/6過去の実績0/6財務の健全性6/6配当金0/6報酬当社が推定した公正価値より99.9%で取引されている 収益は年間59.03%増加すると予測されています リスク分析意味のある時価総額がありません ( €5M )株式の流動性は非常に低い 収益が 100 万ドル未満 ( $508K )過去1年間で株主の希薄化は大幅に進んだ +1 さらなるリスクすべてのリスクチェックを見るC970 Community Fair Values Create NarrativeSee what others think this stock is worth. Follow their fair value or set your own to get alerts.Your Fair Value€Current Price€9.96723.1% 割高 内在価値ディスカウントEst. Revenue$PastFuture-52m105m2016201920222025202620282031Revenue US$5.2mEarnings US$668.6kAdvancedSet Fair ValueView all narrativesCo-Diagnostics, Inc. 競合他社NanoReproSymbol: XTRA:NN6Market cap: €22.3mGeratherm MedicalSymbol: XTRA:GMEMarket cap: €14.6maap ImplantateSymbol: XTRA:AAQ1Market cap: €26.4mRedsense MedicalSymbol: DB:R0ZMarket cap: €67.4m価格と性能株価の高値、安値、推移の概要Co-Diagnostics過去の株価現在の株価US$9.9652週高値US$32.4052週安値US$8.76ベータ1.321ヶ月の変化0%3ヶ月変化n/a1年変化-48.13%3年間の変化n/a5年間の変化-96.98%IPOからの変化-69.54%最新ニュースお知らせ • Jun 02Co-Diagnostics and Cosara Advance Ebola Pcr Test Development and Co-Dx Pcr Point-Of-Care Platform CapabilitiesCo-Diagnostics, Inc. announced continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. The program includes development of both a pan-Ebola assay designed to rapidly detect multiple ebolavirus species and a multiplex assay capable of differentiating among Sudan, Taï Forest, Zaire, and Bundibugyo ebolaviruses currently associated with outbreaks in Central Africa. This dual-assay strategy is intended to provide flexibility in supporting outbreak response efforts, including those of potential NGO partners, subject to future development, validation, regulatory review, and deployment requirements. The Ebola PCR assay workflow configurations also being developed to support point-of-care environments for the Co-Dx PCR point-of-care platform would represent the first blood-based pathogen assay designed for use on the Co-Dx PCR Pro. This would significantly expand the platform's capabilities beyond swab-based infectious disease testing and increase the range of potential applications that may be addressed through future menu expansion. Many of the world's most serious infectious diseases are identified using blood samples, and expanding the platform to support those applications would represent an important step forward for Co-Diagnostics. The ability to bring rapid, high-quality PCR testing closer to patients, whether through respiratory, tuberculosis, HPV, or blood-borne disease applications, supports the broader goal of making molecular diagnostics more accessible in both developed and emerging markets. The Co-Dx PCR platform (including the PCR Home, PCR Pro, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.お知らせ • May 26Co-Diagnostics Advances Ebola Pcr Assay Development Strategy with Joint Venture CosaraCo-Diagnostics, Inc. has advanced the PCR assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo ("DRC") and Uganda, with the support of CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV"), the Indian joint venture between Co-Dx and Ambalal Sarabhai Enterprises Limited ("ASE Group"). The joint assay development strategy is expected to more rapidly address the needs of the international community if the current outbreak expands globally, or if localized governmental or non-governmental support is needed in the areas of DRC and Uganda. CoSara's regional manufacturing and operational capabilities may support rapid deployment initiatives in certain international markets, subject to applicable regulatory requirements. The proposed development program includes evaluation of both BDBV-specific and pan-Ebola assay configurations designed to detect multiple ebolavirus species. The Company is also evaluating workflow configurations intended to support point-of-care and decentralized testing environments for the Co-Dx PCR point-of-care platform. The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. On May 25, the World Health Organization ("WHO") reported that the outbreak of Ebola disease caused by BDBV, which the WHO Director-General declared a public health emergency of international concern ("PHEIC") on May 17, 2026, has resulted in more than 900 suspected cases and 220 suspected deaths, and that the epidemic is currently outpacing response operations.お知らせ • May 21Co-Diagnostics Inc Develops Ebola Assay StrategyCo-Diagnostics, Inc. has completed the assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo and Uganda. On May 17, WHO declared an outbreak of Ebola disease caused by BDBV as a public health emergency of international concern ("PHEIC"). As of May 17, eight laboratory-confirmed cases, 246 suspected cases, and 80 suspected deaths have been reported in the Democratic Republic of the Congo, along with two laboratory-confirmed cases and one reported death in Uganda. The announcement also follows recent guidance from the U.S. Centers for Disease Control and Prevention ("CDC") regarding enhanced screening and monitoring measures for travelers arriving from regions impacted by Ebola outbreaks. According to the CDC, these measures include increased traveler monitoring, contact tracing coordination, and enhanced hospital preparedness efforts, underscoring the importance of rapid testing and real-time outbreak visibility in responding to emerging infectious disease threats. The Co-Dx PCR platform (including the PCR Home, PCR Pro, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.お知らせ • May 20Co-Diagnostics, Inc. announced that it expects to receive $3 million in fundingCo-Diagnostics, Inc. announced that it has entered into a securities purchase agreement with certain institutional investors to sell an aggregate of 1,647,447 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 3,294,894 shares of common stock, in a private placement priced at-the-market under Nasdaq rules for gross proceeds of $3,000,000 on May 19, 2026. The combined effective offering price for each share of common stock (or pre-funded warrant in-lieu thereof) and accompanying warrants to be issued is $1.821. The warrants will have an exercise price of $1.571 per share, will be exercisable immediately upon issuance, and will expire five years from the date of issuance. The Offering is expected to close on or about May 21, 2026, subject to the satisfaction of customary closing conditions. The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement.お知らせ • Apr 30Co-Diagnostics, Inc. to Report Q1, 2026 Results on May 14, 2026Co-Diagnostics, Inc. announced that they will report Q1, 2026 results After-Market on May 14, 2026お知らせ • Apr 15Co-Diagnostics, Inc. Showcases Co-Dx Pcr Platform and Ce-Ivd Solutions At Escmid Global 2026 in Munich, GermanyCo-Diagnostics, Inc. announced it will participate in the Congress of the European Society of Clinical Microbiology and Infectious Disease ESCMID Global 2026, taking place April 17-21 in Munich, Germany. ESCMID Global 2026 features academic and industry programming that brings together clinical microbiology and infectious diseases leaders dedicated to advancing scientific, education, research and technologies. Prior ESCMID Global events have historically attracted more than 16,000 registrants, nearly a third of which originated from outside of Europe, underscoring its role as the premier global forum for the infectious disease community. Company representatives look forward to establishing and strengthening relationships with new and existing customers and distributors from around the world while also showcasing the Company's suite of CE-IVD testing solutions for clinical laboratories, as well as the upcoming Co-Dx PCR platform. Registrants interested in learning more about Co-Diagnostics are invited to visit Booth #G55. The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.最新情報をもっと見るRecent updatesお知らせ • Jun 02Co-Diagnostics and Cosara Advance Ebola Pcr Test Development and Co-Dx Pcr Point-Of-Care Platform CapabilitiesCo-Diagnostics, Inc. announced continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. The program includes development of both a pan-Ebola assay designed to rapidly detect multiple ebolavirus species and a multiplex assay capable of differentiating among Sudan, Taï Forest, Zaire, and Bundibugyo ebolaviruses currently associated with outbreaks in Central Africa. This dual-assay strategy is intended to provide flexibility in supporting outbreak response efforts, including those of potential NGO partners, subject to future development, validation, regulatory review, and deployment requirements. The Ebola PCR assay workflow configurations also being developed to support point-of-care environments for the Co-Dx PCR point-of-care platform would represent the first blood-based pathogen assay designed for use on the Co-Dx PCR Pro. This would significantly expand the platform's capabilities beyond swab-based infectious disease testing and increase the range of potential applications that may be addressed through future menu expansion. Many of the world's most serious infectious diseases are identified using blood samples, and expanding the platform to support those applications would represent an important step forward for Co-Diagnostics. The ability to bring rapid, high-quality PCR testing closer to patients, whether through respiratory, tuberculosis, HPV, or blood-borne disease applications, supports the broader goal of making molecular diagnostics more accessible in both developed and emerging markets. The Co-Dx PCR platform (including the PCR Home, PCR Pro, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.お知らせ • May 26Co-Diagnostics Advances Ebola Pcr Assay Development Strategy with Joint Venture CosaraCo-Diagnostics, Inc. has advanced the PCR assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo ("DRC") and Uganda, with the support of CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV"), the Indian joint venture between Co-Dx and Ambalal Sarabhai Enterprises Limited ("ASE Group"). The joint assay development strategy is expected to more rapidly address the needs of the international community if the current outbreak expands globally, or if localized governmental or non-governmental support is needed in the areas of DRC and Uganda. CoSara's regional manufacturing and operational capabilities may support rapid deployment initiatives in certain international markets, subject to applicable regulatory requirements. The proposed development program includes evaluation of both BDBV-specific and pan-Ebola assay configurations designed to detect multiple ebolavirus species. The Company is also evaluating workflow configurations intended to support point-of-care and decentralized testing environments for the Co-Dx PCR point-of-care platform. The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. On May 25, the World Health Organization ("WHO") reported that the outbreak of Ebola disease caused by BDBV, which the WHO Director-General declared a public health emergency of international concern ("PHEIC") on May 17, 2026, has resulted in more than 900 suspected cases and 220 suspected deaths, and that the epidemic is currently outpacing response operations.お知らせ • May 21Co-Diagnostics Inc Develops Ebola Assay StrategyCo-Diagnostics, Inc. has completed the assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo and Uganda. On May 17, WHO declared an outbreak of Ebola disease caused by BDBV as a public health emergency of international concern ("PHEIC"). As of May 17, eight laboratory-confirmed cases, 246 suspected cases, and 80 suspected deaths have been reported in the Democratic Republic of the Congo, along with two laboratory-confirmed cases and one reported death in Uganda. The announcement also follows recent guidance from the U.S. Centers for Disease Control and Prevention ("CDC") regarding enhanced screening and monitoring measures for travelers arriving from regions impacted by Ebola outbreaks. According to the CDC, these measures include increased traveler monitoring, contact tracing coordination, and enhanced hospital preparedness efforts, underscoring the importance of rapid testing and real-time outbreak visibility in responding to emerging infectious disease threats. The Co-Dx PCR platform (including the PCR Home, PCR Pro, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.お知らせ • May 20Co-Diagnostics, Inc. announced that it expects to receive $3 million in fundingCo-Diagnostics, Inc. announced that it has entered into a securities purchase agreement with certain institutional investors to sell an aggregate of 1,647,447 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 3,294,894 shares of common stock, in a private placement priced at-the-market under Nasdaq rules for gross proceeds of $3,000,000 on May 19, 2026. The combined effective offering price for each share of common stock (or pre-funded warrant in-lieu thereof) and accompanying warrants to be issued is $1.821. The warrants will have an exercise price of $1.571 per share, will be exercisable immediately upon issuance, and will expire five years from the date of issuance. The Offering is expected to close on or about May 21, 2026, subject to the satisfaction of customary closing conditions. The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement.お知らせ • Apr 30Co-Diagnostics, Inc. to Report Q1, 2026 Results on May 14, 2026Co-Diagnostics, Inc. announced that they will report Q1, 2026 results After-Market on May 14, 2026お知らせ • Apr 15Co-Diagnostics, Inc. Showcases Co-Dx Pcr Platform and Ce-Ivd Solutions At Escmid Global 2026 in Munich, GermanyCo-Diagnostics, Inc. announced it will participate in the Congress of the European Society of Clinical Microbiology and Infectious Disease ESCMID Global 2026, taking place April 17-21 in Munich, Germany. ESCMID Global 2026 features academic and industry programming that brings together clinical microbiology and infectious diseases leaders dedicated to advancing scientific, education, research and technologies. Prior ESCMID Global events have historically attracted more than 16,000 registrants, nearly a third of which originated from outside of Europe, underscoring its role as the premier global forum for the infectious disease community. Company representatives look forward to establishing and strengthening relationships with new and existing customers and distributors from around the world while also showcasing the Company's suite of CE-IVD testing solutions for clinical laboratories, as well as the upcoming Co-Dx PCR platform. Registrants interested in learning more about Co-Diagnostics are invited to visit Booth #G55. The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.お知らせ • Mar 17Co-Diagnostics, Inc. to Report Q4, 2025 Results on Mar 31, 2026Co-Diagnostics, Inc. announced that they will report Q4, 2025 results After-Market on Mar 31, 2026お知らせ • Jan 16Co-Diagnostics, Inc.(OTCPK:CODX) dropped from S&P TMI IndexCo-Diagnostics, Inc.(OTCPK:CODX) dropped from S&P TMI Indexお知らせ • Jan 14+ 1 more updateCo-Diagnostics, Inc.(OTCPK:CODX) dropped from NASDAQ Composite IndexCo-Diagnostics, Inc. has been removed from NASDAQ Composite Index .お知らせ • Dec 18Co-Diagnostics Performs Analysis of Influenza Co-Primers®? to Confirm Reactivity Against Flu A H3n2 MutationCo-Diagnostics, Inc. announced that it has performed an in silico analysis of the Co-Primers®? used in its Logix Smart®? ABC test for the detection of influenza A, influenza B and COVID-19. The analysis showed a high homology against 3,900 influenza sequences, confirming comparable reactivity of the primer sets against the influenza A H3N2 subclade K. According to the World Health Organization, seasonal influenza causes approximately 3-5 million cases of severe illness annually, resulting in 290,000-650,000 respiratory fatalities. This year's flu vaccine is observed with subclade K (or "J.2.4.1"), which has limited natural immunity within communities. influenza A subtype H3N2 has historically been associated with higher rates of hospitalization and death, and preliminary data has already linked subclade K to countries like Japan and the United Kingdom experiencing earlier than usual flu seasons in 2025, following Australia reporting a record flu season. In November 2020, the Logix Smart ABC test received CE-marking for the simultaneous detection of and differentiation of influenza A, influenza B, and SARS-CoV-2, the virus that causes COVID-19. The in silico analysis concluded that there is no concern that any emerging H3N2 strains would affect the test kit's sensitivity. The Logix Smart ABC test is intended for use by qualified and trained clinical laboratory personnel. In November 2025, the Company announced that it had initiated clinical performance testing for the Co-Dx PCR Flu A/B, COVID-19, RSV point-of-care upper-respiratory multiplex test, which is intended to support a submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. Similar to the Logix Smart test, the flu A targets in this test are not expected to be affected by H3N2 subclades K. This test is not approved or cleared by the U.S. Food & Drug Administration (FDA). It is for export only and is not for sale in the United States. The Co-Dx PCR platform (including the Co-Dx PCR Home™?, Co-Dx PCR Pro™?, mobile app, and all associated tests and software) is subject to review by the FDA and/or other regulatory bodies and is not available for sale.Board Change • Nov 26Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 2 highly experienced directors. Chairman of Scientific Advisory Board Carl Wittwer was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.お知らせ • Nov 19Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx™? PCR Platform to Support Submission to the U.S. FDACo-Diagnostics, Inc. announced that it has begun clinical evaluations for its Co-Dx™? PCR Flu A/B, COVID-19, RSV Test Kit. The clinical performance testing is expected to support a submission to the United States Food and Drug Administration ("FDA") for 510(k) clearance of the upper respiratory multiplex point-of-care test, and the Co-Dx PCR Pro™? instrument.Reported Earnings • Nov 15Third quarter 2025 earnings released: US$0.15 loss per share (vs US$0.32 loss in 3Q 2024)Third quarter 2025 results: US$0.15 loss per share (improved from US$0.32 loss in 3Q 2024). Net loss: US$5.89m (loss narrowed 39% from 3Q 2024). Revenue is forecast to grow 71% p.a. on average during the next 2 years, compared to a 5.6% growth forecast for the Medical Equipment industry in Germany.New Risk • Nov 10New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$36m Forecast net loss in 1 year: US$31m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Shareholders have been substantially diluted in the past year (88% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$31m net loss next year). Revenue is less than US$5m (US$1.0m revenue). Market cap is less than US$100m (€21.1m market cap, or US$24.4m).お知らせ • Oct 31Co-Diagnostics, Inc. to Report Q3, 2025 Results on Nov 13, 2025Co-Diagnostics, Inc. announced that they will report Q3, 2025 results After-Market on Nov 13, 2025お知らせ • Oct 30Co-Diagnostics, Inc. has completed a Follow-on Equity Offering in the amount of $6.999927 million.Co-Diagnostics, Inc. has completed a Follow-on Equity Offering in the amount of $6.999927 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 12,002,272 Price\Range: $0.55 Discount Per Security: $0.0385 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 725,000 Price\Range: $0.5499 Discount Per Security: $0.0385 Transaction Features: Registered Direct OfferingBoard Change • Oct 28Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 2 highly experienced directors. Chairman of Scientific Advisory Board Carl Wittwer was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.お知らせ • Oct 28Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $7 million.Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $7 million. Security Name: Common Stock Security Type: Common Stock Security Name: Pre-Funded Warrants Security Type: Equity Warrant Transaction Features: Registered Direct Offeringお知らせ • Oct 21Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $4.086645 million.Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $4.086645 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 4,086,645 Price\Range: $1 Transaction Features: At the Market Offeringお知らせ • Oct 16Co-Diagnostics, Inc. Announces Development of Proprietary Sample Prep Instrument for PoC TestingCo-Diagnostics, Inc. announced the development of a proprietary sample preparation instrument designed to streamline and simplify the workflow for its point-of-care (PoC) Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test. The new instrument has been engineered to deliver a low-cost, user-friendly solution for sample processing in resource-limited PoC and near-PoC settings, supporting both sputum and the novel tongue swab sample collection used in the Company's upcoming MTB test, which is expected to begin clinical evaluations in India before year-end. The single-button operation and no need for measurement or dispensing tools enable rapid sample prep with minimal training, while incorporating a built-in safety feature to inactivate live organisms in the sample and help protect test operators.Breakeven Date Change • Oct 02No longer forecast to breakevenThe 2 analysts covering Co-Diagnostics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$24.9m in 2027. New consensus forecast suggests the company will make a loss of US$20.3m in 2027.お知らせ • Sep 19Co-Diagnostics, Inc. has completed a Follow-on Equity Offering in the amount of $3.8476 million.Co-Diagnostics, Inc. has completed a Follow-on Equity Offering in the amount of $3.8476 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 9,619,000 Price\Range: $0.4 Discount Per Security: $0.028 Transaction Features: Registered Direct Offeringお知らせ • Sep 17+ 1 more updateCo-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $3.8476 million.Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $3.8476 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 9,619,000 Price\Range: $0.4 Transaction Features: Registered Direct Offeringお知らせ • Sep 11Co-Diagnostics, Inc. Performs Analysis of Chikungunya Co-Primers to Confirm Reactivity Against Known Virus StrainsCo-Diagnostics, Inc. announced that it has performed an in silico analysis of the primers sets used in its Co-Primers-based PCR tests for the detection of chikungunya virus (or "CHIKV"), showing a high homology against over 1,200 CHIKV sequences and confirming reactivity of the CHIKV primers against known recent strains of the virus. As of July, there have been nearly 250,000 cases and 90 deaths from CHIKV worldwide, primarily concentrated in South America, but also found in countries across Africa, Asia and Europe. An estimated 5.6 billion people currently live in at-risk areas across 119 countries as warming trends contribute to expanded regions for the mosquitoes that can carry CHIKV. Chikungunya imposes a significant economic burden, especially in low- and middle-income countries. Long-term consequences for the patient are also common, particularly joint pain that can be debilitating, with 40% of people contracting chronic chikungunya arthritis, leading to the pain lasting months or even years according to the Mayo Clinic. Less common complications include auto-immune disorders and chronic fatigue. The Co-Diagnostics Logix Smart®? ZDC Test received CE-marking regulatory clearance in 2019 to be sold as an in vitro diagnostic ("IVD") for the viruses that cause Zika, dengue and chikungunya. The test functions via the Company's patented Co-Primers technology and a single-step reverse transcriptase real-time PCR process to detect and differentiate between the viral RNA of Zika, dengue (all 4 serotypes), and chikungunya in blood drawn from patients. It is available for markets that accept CE-marking as valid regulatory clearance, pending local product registration requirements. Differentiating CHIKV cases from other infections with similar symptoms, such as dengue, helps physicians avoid administering certain pain and fever medications that can increase risk of bleeding and be life-threatening in patients with severe dengue infections. As an arbovirus spread by mosquitoes, accurate diagnosis is also vital to indicate to an infected patient that they should take additional precautions to limit contact with mosquitoes, to prevent further spread of the virus. Co-Dx also offers its Co-Primers-based environmental use only Vector Smart VZDC Test to mosquito abatement districts ("MADs"), as part of its suite of vector control tests used by around 30 MADs across approximately 20 U.S. states to identify pathogens such as Zika, dengue, chikungunya, West Nile virus, St. Louis encephalitis, and Eastern and Western equine encephalitis in mosquito pools. The Vector Smart VZDC Test CHIKV primer sets are the same as those used in the Logix Smart ZDC test. Co-Diagnostics Indian joint venture CoSara Diagnostics Pvt Ltd. received clearance in October 2021 by Indian authorities to manufacture and sell its SaraGene Dengue and Chikungunya Multiplex RT-PCR test as an IVD, which is also built on the Company's Co-Primers platform technology. This product is for export only and is not for sale in the United States.お知らせ • Jul 31Co-Diagnostics, Inc. to Report Q2, 2025 Results on Aug 14, 2025Co-Diagnostics, Inc. announced that they will report Q2, 2025 results After-Market on Aug 14, 2025お知らせ • Apr 29Co-Diagnostics, Inc. to Report Q1, 2025 Results on May 08, 2025Co-Diagnostics, Inc. announced that they will report Q1, 2025 results After-Market on May 08, 2025お知らせ • Apr 16Co-Diagnostics, Inc., Annual General Meeting, May 28, 2025Co-Diagnostics, Inc., Annual General Meeting, May 28, 2025. Location: company s offices located at 2401 s. foothilldr, ste. d, slc, utah 84109, United Statesお知らせ • Mar 13Co-Diagnostics, Inc. to Report Q4, 2024 Results on Mar 27, 2025Co-Diagnostics, Inc. announced that they will report Q4, 2024 results After-Market on Mar 27, 2025お知らせ • Mar 07Co-Diagnostics, Inc. Wins Dismissal of Class Action LawsuitCo-Diagnostics, Inc. announced that on March 4, 2025, the Securities & Governance Litigation Team at BakerHostetler, the legal firm retained to represent the Company, won complete dismissal on summary judgment of a Section 10(b) securities class action that had been pending against the Company in the United States District Court for the District of Utah. On June 15, 2020, Plaintiff Gelt Trading Ltd. filed a securities class action against Co-Diagnostics, Inc. and certain of the Company's current and former directors and officers alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.At issue was the Company's May 1, 2020, press release, which disclosed, among other things, that the Company's Logix Smart® COVID-19 test demonstrated "100% sensitivity and 100% specificity"—well-defined scientific metrics—across independent evaluations. Plaintiff alleged that the May 1 press release was false and/or misleading because it conveyed to investors that the Logix Smart test was "100% accurate" (i.e., perfect), allegedly causing the Company's stock price to be artificially inflated. Plaintiff alleged that this artificial inflation was removed, and investors suffered losses, when the Company's stock price dropped on May 15 following three disclosures that allegedly revealed the May 1 press release to be false ("Alleged Corrective Disclosures"). BakerHostetler was retained to replace prior counsel after the motion to dismiss was denied and the case was in the early phases of discovery. On summary judgment, BakerHostetler argued that Plaintiff could not establish any genuine issue of material fact supporting liability as to any element of its Section 10(b) claim—falsity, scienter, reliance, loss causation, or damages. BakerHostetler also argued that Plaintiff's experts' testimony—which related to clinical testing and loss causation—should be excluded on summary judgment under Daubert. On March 4, 2025, after oral argument, the Court granted Defendants' Daubert motion to exclude the testimony of Plaintiff's loss causation expert and granted summary judgment for Defendants, concluding that Plaintiff could not demonstrate loss causation. The Court held that none of the three Alleged Corrective Disclosures actually "corrected" the May 1 press release, either because they did not discuss the Company's Logix Smart test, or because the allegedly contradictory information was long known to the market and already baked into the Company's stock price. Accordingly, Plaintiff could not establish that the May 1 press release was the cause of Plaintiff's or the class's losses. Having reached this conclusion, the Court declined to address the other summary judgment arguments or Daubert motions. The Company regards this dismissal as a tremendous victory and is optimistic about its chances of prevailing in any appeal Plaintiff might file. The Company looks forward to putting the matter behind it, as it moves ahead with its mission of increasing the availability of high-quality molecular diagnostics on a global scale.お知らせ • Feb 22Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) ClearanceCo-Diagnostics, Inc. announced that, following a collaborative and informative dialogue with the Food and Drug Administration (FDA), the Company has withdrawn its 510(k) application to the FDA for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™*, in favor of submitting an enhanced version of the test for 510(k) clearance. Co-Dx is pleased with the productive engagement with the FDA related to the initial regulatory submission and with the performance of the test in clinical evaluations, including performance data and functionality of the instrument. The decision by the Company to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, Co-Dx has determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process. The Company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test's performance. A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the COVID-19 test, which Co-Dx believes will also help to create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care platform. The Company's primary objective is to execute a robust development and commercialization plan for the Co-Dx PCR platform, including ongoing innovations to the PCR Pro instrument. The Co-Dx PCR COVID-19 test is expected to be followed by additional tests for tuberculosis, upper-respiratory multiplex, and a multiplex HPV test, among others.お知らせ • Jan 11Co-Diagnostics Receives a Notice from Nasdaq Listing Qualifications Department of the Nasdaq Stock MarketOn January 10, 2025, Co-Diagnostics, Inc. received a notice from Nasdaq Listing Qualifications department of the Nasdaq Stock Market LLC (“Nasdaq”) stating that the closing bid price of the Company’s common stock for the last 30 consecutive business days had closed below the minimum $1.00 per share required for continued listing under Listing Rule 5550(a)(2). The Company has a period of 180 calendar days, or until July 9, 2025 (the “Compliance Date”), to regain compliance with Listing Rule 5550(a)(2). To regain compliance, the bid price of the Company’s common stock must close at $1 or more for a minimum of ten consecutive business days before the Compliance Date. The Nasdaq notification letter does not result in the immediate delisting of the Company’s common stock, and the stock will continue to trade uninterrupted on the The Nasdaq Capital Market under the symbol “CODX”. If the Company does not regain compliance with Rule 5550(a)(2) by the Compliance Date, the Company may be eligible for additional time. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company meets these requirements, the Staff will inform the Company that it has been granted an additional 180 calendar days. However, if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, the Staff will provide notice that its securities will be subject to delisting.お知らせ • Oct 26Co-Diagnostics, Inc. to Report Q3, 2024 Results on Nov 07, 2024Co-Diagnostics, Inc. announced that they will report Q3, 2024 results After-Market on Nov 07, 2024お知らせ • Jul 25Co-Diagnostics, Inc. to Report Q2, 2024 Results on Aug 08, 2024Co-Diagnostics, Inc. announced that they will report Q2, 2024 results After-Market on Aug 08, 2024お知らせ • Jul 17Co-Diagnostics, Inc., Annual General Meeting, Aug 29, 2024Co-Diagnostics, Inc., Annual General Meeting, Aug 29, 2024.お知らせ • Jun 15Co-Diagnostics, Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro PlatformCo-Diagnostics, Inc. announced that the Company has completed its first U.S. Food and Drug Administration (FDA) application for 510(k) clearance for the Co-Dx PCR Pro instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use. Co-Diagnostics completed the submission via the FDA's electronic Submissions Template And Resource (eSTAR) system, and have received the acknowledgement from the FDA that the 510(k) application was received. eSTAR serves as a comprehensive resource for medical device manufacturers to standardize and consolidate the necessary information and links needed for 510(k) submission preparation. The Co-Dx PCR platform has been designed to help close the access gap for infectious disease diagnosis by facilitating the widespread decentralization of gold-standard PCR diagnostics, which have historically only been found in high-complexity clinical laboratories. It consists of a compact and robust real-time PCR instrument operated at point-of-care or in at-home settings via an intuitive smartphone interface, with test cups powered by patented Co-Primers technology. The Company is also preparing to shortly pursue clearance for the Co-D x PCR COVID-19 test on the new instrument, to be used for point-of-care testing (POCT). Other diagnostics for the platform in varying stages of development or preparation for clinical evaluations include tests for tuberculosis, human papillomavirus, strep A, and a respiratory multiplex that detects influenza A and B, COVID-19 and RSV in a single test. The Co-Dx PCR platform (including the PCR Home, PCR Pro, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.お知らせ • Apr 27Co-Diagnostics, Inc. to Report Q1, 2024 Results on May 09, 2024Co-Diagnostics, Inc. announced that they will report Q1, 2024 results After-Market on May 09, 2024お知らせ • Apr 04Co-Diagnostics, Inc. Appoints Executive AppointmentsCo-Diagnostics, Inc. appointed David Nielsen to be its Chief Operations Officer (COO), Christopher Thurston as its Chief Technology Officer (CTO), and Seth Egan as Chief Commercialization Officer (CCO). David Nielsen (COO) previously held the role of COO for Idaho Molecular, also acquired by Co-Dx in 2021, and has worked in concert with Advanced Conceptions and Co-Dx to help guide the development of the Company's new platform since that time. Including his time at Idaho Molecular, Mr. Nielsen has over 25 years of R&D technical and leadership experience, primarily at BioFire and BioFire Defense, filling various key roles which also included managing and coordinating the FilmArray diagnostic system throughout development and launch as the VP of Product Development. David earned both a Master of Science and M.B.A. from the University of Utah. As COO, David will leverage his experience to help lead Co-Dx's product development and manufacturing processes. Christopher Thurston's (CTO) distinguished career has included decades of experience serving as senior developer and architect of software platforms for companies including Ernst and Young, BioFire Defense, and BioMerieux, demonstrating his expertise in big-data solutions. Following his experience in executive positions at several startups, Christopher co-invented the Co-Dx PCR platform at Idaho Molecular, pursuing his passion for democratizing access to PCR diagnostics though technological innovation. Mr. Thurston's technology expertise will be significant in the advancement of Co-Dx's platform and tests. Seth Egan (CCO) has been with Co-Dx since its inception, leading the Company's sales, marketing and product commercialization efforts from the beginning, including managing the sales team as it sold approximately 35M Logix Smart® tests to centralized laboratories in more than 50 countries since the beginning of the pandemic. Mr. Egan has operated in many key capacities for the Company and continues to play an important role helping to oversee the relationship with CoSara Diagnostics, the Co-Dx joint venture in India. He holds a Bachelor of Science in Business Communications from Utah Valley University. Mr. Egan will play a crucial role as CCO in driving the Co-Dx PCR platform's commercialization efforts.お知らせ • Mar 01Co-Diagnostics, Inc. to Report Q4, 2023 Results on Mar 14, 2024Co-Diagnostics, Inc. announced that they will report Q4, 2023 results at 4:00 PM, US Eastern Standard Time on Mar 14, 2024お知らせ • Dec 27Co-Diagnostics, Inc. Completes Submission to FDA for Co-Dx PCR ProCo-Diagnostics, Inc. announced that it has submitted its Co-Dx™? PCR COVID-19 test with Co-Dx PCR Pro™? instrument for review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). The submission includes the PCR Pro instrument, COVID-19 detection test, and mobile app, all designed for use in point-of-care and at-home settings. Tests run on the new platform use the Company's patented real-time polymerase chain reaction (PCR) Co-Primers™? technology. The Co-Dx COVID-19 test kit for the PCR Pro instrument included in the Company's FDA submission has been shown in clinical evaluations to detect the presence of COVID-19 in anterior nasal swab samples, with results displayed on the user's smartphone or mobile device in approximately 30 minutes. The menu of future tests that are currently in development for the new platform includes tuberculosis (TB) and human papillomavirus (HPV), as well as an upper respiratory multiplex panel that will detect influenza A/B, COVID-19, and respiratory syncytial virus (RSV) within a single sample. All three tests have also been the subject of grant support by notable funding bodies over the last half of this year.お知らせ • Oct 27Co-Diagnostics, Inc. to Report Q3, 2023 Results on Nov 09, 2023Co-Diagnostics, Inc. announced that they will report Q3, 2023 results After-Market on Nov 09, 2023お知らせ • Aug 30Co-Diagnostics, Inc. Appoints Ivory Chang as Chief Regulatory Affairs OfficerCo-Diagnostics, Inc. announced the appointment of Ivory Chang as the Company's Chief Regulatory Affairs Officer. Ms. Chang's in-depth regulatory affairs experience has included time spent with several notable names in the diagnostics industry, including Roche, Boston Scientific, BD Biosciences, Cepheid, Thermo Fisher Scientific, and more. Her background has involved regulatory and registration submissions to major regulatory bodies around the world for infectious disease, oncology, point-of-care, in vitro diagnostics (IVD), and software diagnostic products.お知らせ • Jul 29Co-Diagnostics, Inc. to Report Q2, 2023 Results on Aug 10, 2023Co-Diagnostics, Inc. announced that they will report Q2, 2023 results After-Market on Aug 10, 2023お知らせ • Jul 23Co-Diagnostics, Inc., Annual General Meeting, Aug 30, 2023Co-Diagnostics, Inc., Annual General Meeting, Aug 30, 2023, at 10:00 Mountain Standard Time. Agenda: To elect the two (2) Class II director nominees, each of whom are currently serving on company's board of directors, each to serve until the 2026 annual meeting of shareholders or until their successors are duly elected and qualified, or until his or her earlier death, resignation, or removal; to approve, on an advisory basis, the compensation of the Company’s named executive officers; to ratify the appointment of Tanner LLC as our independent registered public accounting firm for the fiscal year ending December 31, 2023; and to consider other business matters.お知らせ • Jul 14Co-Diagnostics, Inc. Receives Funding for Co-Dx PCR Home Platform from NIH RADx Tech ProgramCo-Diagnostics, Inc. announced that it has been awarded $1.2 million in funding from the National Institutes of Health (NIH) as part of the Rapid Acceleration of Diagnostics (RADx®) Tech program for completion of its upcoming upper respiratory panel on the Company's Co-Dx PCR Home™ testing platform. Co-Diagnostics will utilize the funds from the RADx Tech award to complete development of its flu A/B, COVID-19, and RSV multiplex test, preparatory for that test to begin clinical trials on the Co-Dx PCR Home. The Co-Dx PCR Home is currently undergoing clinical evaluations in anticipation of its submission to the FDA and an initial product launch for a COVID-19 test. This project has been funded in part with federal funds from the National Institute of Biomedical Imaging (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92023D00001. The Co-Dx PCR Home testing platform and its associated tests are subject to FDA review and are not available for sale.お知らせ • May 06Co-Diagnostics, Inc. to Report Q1, 2023 Results on May 11, 2023Co-Diagnostics, Inc. announced that they will report Q1, 2023 results at 4:00 PM, US Eastern Standard Time on May 11, 2023Valuation Update With 7 Day Price Move • Aug 18Investor sentiment deteriorated over the past weekAfter last week's 32% share price decline to €4.20, the stock trades at a forward P/E ratio of 54x. Average forward P/E is 36x in the Medical Equipment industry in Germany.Reported Earnings • Aug 12Second quarter 2022 earnings released: US$0.083 loss per share (vs US$0.34 profit in 2Q 2021)Second quarter 2022 results: US$0.083 loss per share (down from US$0.34 profit in 2Q 2021). Revenue: US$5.02m (down 82% from 2Q 2021). Net loss: US$2.69m (down 127% from profit in 2Q 2021). Over the next year, revenue is forecast to grow 8.2%, compared to a 7.5% growth forecast for the industry in Germany.Board Change • Jul 27High number of new and inexperienced directorsThere are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 3 experienced directors. 1 highly experienced director. Chairman, CEO & President Dwight Egan is the most experienced director on the board, commencing their role in 2013. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.株主還元C970DE Medical EquipmentDE 市場7D0%2.2%-2.9%1Y-48.1%-27.5%-0.8%株主還元を見る業界別リターン: C970過去 1 年間で-27.5 % の収益を上げたGerman Medical Equipment業界を下回りました。リターン対市場: C970は、過去 1 年間で-0.8 % のリターンを上げたGerman市場を下回りました。価格変動Is C970's price volatile compared to industry and market?C970 volatilityC970 Average Weekly Movementn/aMedical Equipment Industry Average Movement6.2%Market Average Movement5.9%10% most volatile stocks in DE Market13.0%10% least volatile stocks in DE Market2.7%安定した株価: C970の株価は、 German市場と比較して過去 3 か月間で変動しています。時間の経過による変動: 過去 1 年間のC970のボラティリティの変化を判断するには データが不十分です。会社概要設立従業員CEO（最高経営責任者ウェブサイト2013132Dwight Eganco-dx.comCo-Diagnostics, Inc.は、核酸分子の検出および/または分析を通じて機能する診断検査に使用される試薬の開発、製造、販売を行う分子診断薬会社として、米国および海外で事業を展開している。同社はCo-Dx PCRプラットフォームと呼ばれるポリメラーゼ連鎖反応検査をポイントオブケアや在宅で患者に提供している。また、COVID-19、インフルエンザ、結核、B型・C型肝炎、ヒトパピローマウイルス、マラリア、チクングニア、デング熱、ジカウイルスに対するPCR診断検査も提供している。さらに、蚊が媒介する病気を特定するための3種類の多重検査、感染症の検出、がんスクリーニングのためのリキッドバイオプシー、農業用途の分子ツール、動植物ゲノムの遺伝形質を特定する検査、ポイントオブケアや在宅環境でPCRを患者に提供するために設計された携帯型診断装置も提供している。同社は2013年に法人化され、ユタ州ソルトレイクシティに本社を置いている。もっと見るCo-Diagnostics, Inc. 基礎のまとめCo-Diagnostics の収益と売上を時価総額と比較するとどうか。C970 基礎統計学時価総額€4.69m収益（TTM）-€27.31m売上高(TTM)€430.95k10.9xP/Sレシオ-0.2xPER（株価収益率C970 は割高か？公正価値と評価分析を参照収益と収入最新の決算報告書（TTM）に基づく主な収益性統計C970 損益計算書（TTM）収益US$507.89k売上原価US$335.05k売上総利益US$172.84kその他の費用US$32.35m収益-US$32.18m直近の収益報告Sep 30, 2025次回決算日該当なし一株当たり利益（EPS）-14.26グロス・マージン34.03%純利益率-6,336.27%有利子負債／自己資本比率0%C970 の長期的なパフォーマンスは？過去の実績と比較を見るView Valuation企業分析と財務データの現状データ最終更新日（UTC時間）企業分析2026/02/23 16:21終値2025/11/26 00:00収益2025/09/30年間収益2024/12/31データソース企業分析に使用したデータはS&P Global Market Intelligence LLC のものです。本レポートを作成するための分析モデルでは、以下のデータを使用しています。データは正規化されているため、ソースが利用可能になるまでに時間がかかる場合があります。パッケージデータタイムフレーム米国ソース例会社財務10年損益計算書キャッシュ・フロー計算書貸借対照表SECフォーム10-KSECフォーム10-Qアナリストのコンセンサス予想+プラス3年予想財務アナリストの目標株価アナリストリサーチレポートBlue Matrix市場価格30年株価配当、分割、措置ICEマーケットデータSECフォームS-1所有権10年トップ株主インサイダー取引SECフォーム4SECフォーム13Dマネジメント10年リーダーシップ・チーム取締役会SECフォーム10-KSECフォームDEF 14A主な進展10年会社からのお知らせSECフォーム8-K* 米国証券を対象とした例であり、非米国証券については、同等の規制書式および情報源を使用。特に断りのない限り、すべての財務データは1年ごとの期間に基づいていますが、四半期ごとに更新されます。これは、TTM（Trailing Twelve Month）またはLTM（Last Twelve Month）データとして知られています。詳細はこちら。分析モデルとスノーフレーク本レポートを生成するために使用した分析モデルの詳細は当社のGithubページでご覧いただけます。また、レポートの使用方法に関するガイドやYoutubeのチュートリアルも掲載しています。シンプリー・ウォールストリート分析モデルを設計・構築した世界トップクラスのチームについてご紹介します。業界およびセクターの指標私たちの業界とセクションの指標は、Simply Wall Stによって6時間ごとに計算されます。アナリスト筋Co-Diagnostics, Inc. 2 これらのアナリストのうち、弊社レポートのインプットとして使用した売上高または利益の予想を提出したのは、 。アナリストの投稿は一日中更新されます。2 アナリスト機関Jason McCarthyMaxim GroupJames SidotiSidoti & Company, LLC
お知らせ • Jun 02Co-Diagnostics and Cosara Advance Ebola Pcr Test Development and Co-Dx Pcr Point-Of-Care Platform CapabilitiesCo-Diagnostics, Inc. announced continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. The program includes development of both a pan-Ebola assay designed to rapidly detect multiple ebolavirus species and a multiplex assay capable of differentiating among Sudan, Taï Forest, Zaire, and Bundibugyo ebolaviruses currently associated with outbreaks in Central Africa. This dual-assay strategy is intended to provide flexibility in supporting outbreak response efforts, including those of potential NGO partners, subject to future development, validation, regulatory review, and deployment requirements. The Ebola PCR assay workflow configurations also being developed to support point-of-care environments for the Co-Dx PCR point-of-care platform would represent the first blood-based pathogen assay designed for use on the Co-Dx PCR Pro. This would significantly expand the platform's capabilities beyond swab-based infectious disease testing and increase the range of potential applications that may be addressed through future menu expansion. Many of the world's most serious infectious diseases are identified using blood samples, and expanding the platform to support those applications would represent an important step forward for Co-Diagnostics. The ability to bring rapid, high-quality PCR testing closer to patients, whether through respiratory, tuberculosis, HPV, or blood-borne disease applications, supports the broader goal of making molecular diagnostics more accessible in both developed and emerging markets. The Co-Dx PCR platform (including the PCR Home, PCR Pro, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
お知らせ • May 26Co-Diagnostics Advances Ebola Pcr Assay Development Strategy with Joint Venture CosaraCo-Diagnostics, Inc. has advanced the PCR assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo ("DRC") and Uganda, with the support of CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV"), the Indian joint venture between Co-Dx and Ambalal Sarabhai Enterprises Limited ("ASE Group"). The joint assay development strategy is expected to more rapidly address the needs of the international community if the current outbreak expands globally, or if localized governmental or non-governmental support is needed in the areas of DRC and Uganda. CoSara's regional manufacturing and operational capabilities may support rapid deployment initiatives in certain international markets, subject to applicable regulatory requirements. The proposed development program includes evaluation of both BDBV-specific and pan-Ebola assay configurations designed to detect multiple ebolavirus species. The Company is also evaluating workflow configurations intended to support point-of-care and decentralized testing environments for the Co-Dx PCR point-of-care platform. The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. On May 25, the World Health Organization ("WHO") reported that the outbreak of Ebola disease caused by BDBV, which the WHO Director-General declared a public health emergency of international concern ("PHEIC") on May 17, 2026, has resulted in more than 900 suspected cases and 220 suspected deaths, and that the epidemic is currently outpacing response operations.
お知らせ • May 21Co-Diagnostics Inc Develops Ebola Assay StrategyCo-Diagnostics, Inc. has completed the assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo and Uganda. On May 17, WHO declared an outbreak of Ebola disease caused by BDBV as a public health emergency of international concern ("PHEIC"). As of May 17, eight laboratory-confirmed cases, 246 suspected cases, and 80 suspected deaths have been reported in the Democratic Republic of the Congo, along with two laboratory-confirmed cases and one reported death in Uganda. The announcement also follows recent guidance from the U.S. Centers for Disease Control and Prevention ("CDC") regarding enhanced screening and monitoring measures for travelers arriving from regions impacted by Ebola outbreaks. According to the CDC, these measures include increased traveler monitoring, contact tracing coordination, and enhanced hospital preparedness efforts, underscoring the importance of rapid testing and real-time outbreak visibility in responding to emerging infectious disease threats. The Co-Dx PCR platform (including the PCR Home, PCR Pro, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
お知らせ • May 20Co-Diagnostics, Inc. announced that it expects to receive $3 million in fundingCo-Diagnostics, Inc. announced that it has entered into a securities purchase agreement with certain institutional investors to sell an aggregate of 1,647,447 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 3,294,894 shares of common stock, in a private placement priced at-the-market under Nasdaq rules for gross proceeds of $3,000,000 on May 19, 2026. The combined effective offering price for each share of common stock (or pre-funded warrant in-lieu thereof) and accompanying warrants to be issued is $1.821. The warrants will have an exercise price of $1.571 per share, will be exercisable immediately upon issuance, and will expire five years from the date of issuance. The Offering is expected to close on or about May 21, 2026, subject to the satisfaction of customary closing conditions. The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement.
お知らせ • Apr 30Co-Diagnostics, Inc. to Report Q1, 2026 Results on May 14, 2026Co-Diagnostics, Inc. announced that they will report Q1, 2026 results After-Market on May 14, 2026
お知らせ • Apr 15Co-Diagnostics, Inc. Showcases Co-Dx Pcr Platform and Ce-Ivd Solutions At Escmid Global 2026 in Munich, GermanyCo-Diagnostics, Inc. announced it will participate in the Congress of the European Society of Clinical Microbiology and Infectious Disease ESCMID Global 2026, taking place April 17-21 in Munich, Germany. ESCMID Global 2026 features academic and industry programming that brings together clinical microbiology and infectious diseases leaders dedicated to advancing scientific, education, research and technologies. Prior ESCMID Global events have historically attracted more than 16,000 registrants, nearly a third of which originated from outside of Europe, underscoring its role as the premier global forum for the infectious disease community. Company representatives look forward to establishing and strengthening relationships with new and existing customers and distributors from around the world while also showcasing the Company's suite of CE-IVD testing solutions for clinical laboratories, as well as the upcoming Co-Dx PCR platform. Registrants interested in learning more about Co-Diagnostics are invited to visit Booth #G55. The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
お知らせ • Jun 02Co-Diagnostics and Cosara Advance Ebola Pcr Test Development and Co-Dx Pcr Point-Of-Care Platform CapabilitiesCo-Diagnostics, Inc. announced continued progress in its Ebola PCR development program with joint venture CoSara Diagnostics Pvt. Ltd. The program includes development of both a pan-Ebola assay designed to rapidly detect multiple ebolavirus species and a multiplex assay capable of differentiating among Sudan, Taï Forest, Zaire, and Bundibugyo ebolaviruses currently associated with outbreaks in Central Africa. This dual-assay strategy is intended to provide flexibility in supporting outbreak response efforts, including those of potential NGO partners, subject to future development, validation, regulatory review, and deployment requirements. The Ebola PCR assay workflow configurations also being developed to support point-of-care environments for the Co-Dx PCR point-of-care platform would represent the first blood-based pathogen assay designed for use on the Co-Dx PCR Pro. This would significantly expand the platform's capabilities beyond swab-based infectious disease testing and increase the range of potential applications that may be addressed through future menu expansion. Many of the world's most serious infectious diseases are identified using blood samples, and expanding the platform to support those applications would represent an important step forward for Co-Diagnostics. The ability to bring rapid, high-quality PCR testing closer to patients, whether through respiratory, tuberculosis, HPV, or blood-borne disease applications, supports the broader goal of making molecular diagnostics more accessible in both developed and emerging markets. The Co-Dx PCR platform (including the PCR Home, PCR Pro, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
お知らせ • May 26Co-Diagnostics Advances Ebola Pcr Assay Development Strategy with Joint Venture CosaraCo-Diagnostics, Inc. has advanced the PCR assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo ("DRC") and Uganda, with the support of CoSara Diagnostics Pvt. Ltd. ("CoSara" or the "JV"), the Indian joint venture between Co-Dx and Ambalal Sarabhai Enterprises Limited ("ASE Group"). The joint assay development strategy is expected to more rapidly address the needs of the international community if the current outbreak expands globally, or if localized governmental or non-governmental support is needed in the areas of DRC and Uganda. CoSara's regional manufacturing and operational capabilities may support rapid deployment initiatives in certain international markets, subject to applicable regulatory requirements. The proposed development program includes evaluation of both BDBV-specific and pan-Ebola assay configurations designed to detect multiple ebolavirus species. The Company is also evaluating workflow configurations intended to support point-of-care and decentralized testing environments for the Co-Dx PCR point-of-care platform. The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. On May 25, the World Health Organization ("WHO") reported that the outbreak of Ebola disease caused by BDBV, which the WHO Director-General declared a public health emergency of international concern ("PHEIC") on May 17, 2026, has resulted in more than 900 suspected cases and 220 suspected deaths, and that the epidemic is currently outpacing response operations.
お知らせ • May 21Co-Diagnostics Inc Develops Ebola Assay StrategyCo-Diagnostics, Inc. has completed the assay development strategy for the Bundibugyo virus ("BDBV") currently causing an outbreak of Ebola disease in the Democratic Republic of the Congo and Uganda. On May 17, WHO declared an outbreak of Ebola disease caused by BDBV as a public health emergency of international concern ("PHEIC"). As of May 17, eight laboratory-confirmed cases, 246 suspected cases, and 80 suspected deaths have been reported in the Democratic Republic of the Congo, along with two laboratory-confirmed cases and one reported death in Uganda. The announcement also follows recent guidance from the U.S. Centers for Disease Control and Prevention ("CDC") regarding enhanced screening and monitoring measures for travelers arriving from regions impacted by Ebola outbreaks. According to the CDC, these measures include increased traveler monitoring, contact tracing coordination, and enhanced hospital preparedness efforts, underscoring the importance of rapid testing and real-time outbreak visibility in responding to emerging infectious disease threats. The Co-Dx PCR platform (including the PCR Home, PCR Pro, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
お知らせ • May 20Co-Diagnostics, Inc. announced that it expects to receive $3 million in fundingCo-Diagnostics, Inc. announced that it has entered into a securities purchase agreement with certain institutional investors to sell an aggregate of 1,647,447 shares of common stock (or pre-funded warrants in-lieu thereof), together with warrants to purchase up to an aggregate 3,294,894 shares of common stock, in a private placement priced at-the-market under Nasdaq rules for gross proceeds of $3,000,000 on May 19, 2026. The combined effective offering price for each share of common stock (or pre-funded warrant in-lieu thereof) and accompanying warrants to be issued is $1.821. The warrants will have an exercise price of $1.571 per share, will be exercisable immediately upon issuance, and will expire five years from the date of issuance. The Offering is expected to close on or about May 21, 2026, subject to the satisfaction of customary closing conditions. The offer and sale of the foregoing securities are being made in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act"), and/or Regulation D promulgated thereunder, and the securities have not been registered under the Securities Act or applicable state securities laws. Accordingly, the securities may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. The Company has agreed to file a registration statement with the Securities and Exchange Commission registering the resale of the securities purchased in the private placement.
お知らせ • Apr 30Co-Diagnostics, Inc. to Report Q1, 2026 Results on May 14, 2026Co-Diagnostics, Inc. announced that they will report Q1, 2026 results After-Market on May 14, 2026
お知らせ • Apr 15Co-Diagnostics, Inc. Showcases Co-Dx Pcr Platform and Ce-Ivd Solutions At Escmid Global 2026 in Munich, GermanyCo-Diagnostics, Inc. announced it will participate in the Congress of the European Society of Clinical Microbiology and Infectious Disease ESCMID Global 2026, taking place April 17-21 in Munich, Germany. ESCMID Global 2026 features academic and industry programming that brings together clinical microbiology and infectious diseases leaders dedicated to advancing scientific, education, research and technologies. Prior ESCMID Global events have historically attracted more than 16,000 registrants, nearly a third of which originated from outside of Europe, underscoring its role as the premier global forum for the infectious disease community. Company representatives look forward to establishing and strengthening relationships with new and existing customers and distributors from around the world while also showcasing the Company's suite of CE-IVD testing solutions for clinical laboratories, as well as the upcoming Co-Dx PCR platform. Registrants interested in learning more about Co-Diagnostics are invited to visit Booth #G55. The Co-Dx PCR platform (including the PCR Home®, PCR Pro®, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale.
お知らせ • Mar 17Co-Diagnostics, Inc. to Report Q4, 2025 Results on Mar 31, 2026Co-Diagnostics, Inc. announced that they will report Q4, 2025 results After-Market on Mar 31, 2026
お知らせ • Jan 16Co-Diagnostics, Inc.(OTCPK:CODX) dropped from S&P TMI IndexCo-Diagnostics, Inc.(OTCPK:CODX) dropped from S&P TMI Index
お知らせ • Jan 14+ 1 more updateCo-Diagnostics, Inc.(OTCPK:CODX) dropped from NASDAQ Composite IndexCo-Diagnostics, Inc. has been removed from NASDAQ Composite Index .
お知らせ • Dec 18Co-Diagnostics Performs Analysis of Influenza Co-Primers®? to Confirm Reactivity Against Flu A H3n2 MutationCo-Diagnostics, Inc. announced that it has performed an in silico analysis of the Co-Primers®? used in its Logix Smart®? ABC test for the detection of influenza A, influenza B and COVID-19. The analysis showed a high homology against 3,900 influenza sequences, confirming comparable reactivity of the primer sets against the influenza A H3N2 subclade K. According to the World Health Organization, seasonal influenza causes approximately 3-5 million cases of severe illness annually, resulting in 290,000-650,000 respiratory fatalities. This year's flu vaccine is observed with subclade K (or "J.2.4.1"), which has limited natural immunity within communities. influenza A subtype H3N2 has historically been associated with higher rates of hospitalization and death, and preliminary data has already linked subclade K to countries like Japan and the United Kingdom experiencing earlier than usual flu seasons in 2025, following Australia reporting a record flu season. In November 2020, the Logix Smart ABC test received CE-marking for the simultaneous detection of and differentiation of influenza A, influenza B, and SARS-CoV-2, the virus that causes COVID-19. The in silico analysis concluded that there is no concern that any emerging H3N2 strains would affect the test kit's sensitivity. The Logix Smart ABC test is intended for use by qualified and trained clinical laboratory personnel. In November 2025, the Company announced that it had initiated clinical performance testing for the Co-Dx PCR Flu A/B, COVID-19, RSV point-of-care upper-respiratory multiplex test, which is intended to support a submission to the U.S. Food and Drug Administration (FDA) for 510(k) clearance. Similar to the Logix Smart test, the flu A targets in this test are not expected to be affected by H3N2 subclades K. This test is not approved or cleared by the U.S. Food & Drug Administration (FDA). It is for export only and is not for sale in the United States. The Co-Dx PCR platform (including the Co-Dx PCR Home™?, Co-Dx PCR Pro™?, mobile app, and all associated tests and software) is subject to review by the FDA and/or other regulatory bodies and is not available for sale.
Board Change • Nov 26Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 2 highly experienced directors. Chairman of Scientific Advisory Board Carl Wittwer was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.
お知らせ • Nov 19Co-Diagnostics Initiates Clinical Evaluations for Upper Respiratory Multiplex Point-of-Care Test on Co-Dx™? PCR Platform to Support Submission to the U.S. FDACo-Diagnostics, Inc. announced that it has begun clinical evaluations for its Co-Dx™? PCR Flu A/B, COVID-19, RSV Test Kit. The clinical performance testing is expected to support a submission to the United States Food and Drug Administration ("FDA") for 510(k) clearance of the upper respiratory multiplex point-of-care test, and the Co-Dx PCR Pro™? instrument.
Reported Earnings • Nov 15Third quarter 2025 earnings released: US$0.15 loss per share (vs US$0.32 loss in 3Q 2024)Third quarter 2025 results: US$0.15 loss per share (improved from US$0.32 loss in 3Q 2024). Net loss: US$5.89m (loss narrowed 39% from 3Q 2024). Revenue is forecast to grow 71% p.a. on average during the next 2 years, compared to a 5.6% growth forecast for the Medical Equipment industry in Germany.
New Risk • Nov 10New minor risk - ProfitabilityThe company is currently unprofitable and not forecast to become profitable over the next year. Trailing 12-month net loss: US$36m Forecast net loss in 1 year: US$31m This is considered a minor risk. Companies that are not profitable are more likely to be burning through cash and less likely to be well established. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. Without profits, the company is under pressure to grow significantly while potentially having to reduce costs and possibly needing to take on debt or raise capital to remain afloat. Currently, the following risks have been identified for the company: Major Risks Shares are highly illiquid. Shareholders have been substantially diluted in the past year (88% increase in shares outstanding). Minor Risks Currently unprofitable and not forecast to become profitable next year (US$31m net loss next year). Revenue is less than US$5m (US$1.0m revenue). Market cap is less than US$100m (€21.1m market cap, or US$24.4m).
お知らせ • Oct 31Co-Diagnostics, Inc. to Report Q3, 2025 Results on Nov 13, 2025Co-Diagnostics, Inc. announced that they will report Q3, 2025 results After-Market on Nov 13, 2025
お知らせ • Oct 30Co-Diagnostics, Inc. has completed a Follow-on Equity Offering in the amount of $6.999927 million.Co-Diagnostics, Inc. has completed a Follow-on Equity Offering in the amount of $6.999927 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 12,002,272 Price\Range: $0.55 Discount Per Security: $0.0385 Security Name: Pre-Funded Warrants Security Type: Equity Warrant Securities Offered: 725,000 Price\Range: $0.5499 Discount Per Security: $0.0385 Transaction Features: Registered Direct Offering
Board Change • Oct 28Insufficient new directorsNo new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 6 experienced directors. 2 highly experienced directors. Chairman of Scientific Advisory Board Carl Wittwer was the last director to join the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment.
お知らせ • Oct 28Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $7 million.Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $7 million. Security Name: Common Stock Security Type: Common Stock Security Name: Pre-Funded Warrants Security Type: Equity Warrant Transaction Features: Registered Direct Offering
お知らせ • Oct 21Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $4.086645 million.Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $4.086645 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 4,086,645 Price\Range: $1 Transaction Features: At the Market Offering
お知らせ • Oct 16Co-Diagnostics, Inc. Announces Development of Proprietary Sample Prep Instrument for PoC TestingCo-Diagnostics, Inc. announced the development of a proprietary sample preparation instrument designed to streamline and simplify the workflow for its point-of-care (PoC) Co-Dx PCR Mycobacterium Tuberculosis (MTB) Test. The new instrument has been engineered to deliver a low-cost, user-friendly solution for sample processing in resource-limited PoC and near-PoC settings, supporting both sputum and the novel tongue swab sample collection used in the Company's upcoming MTB test, which is expected to begin clinical evaluations in India before year-end. The single-button operation and no need for measurement or dispensing tools enable rapid sample prep with minimal training, while incorporating a built-in safety feature to inactivate live organisms in the sample and help protect test operators.
Breakeven Date Change • Oct 02No longer forecast to breakevenThe 2 analysts covering Co-Diagnostics no longer expect the company to break even during the foreseeable future. The company was expected to make a profit of US$24.9m in 2027. New consensus forecast suggests the company will make a loss of US$20.3m in 2027.
お知らせ • Sep 19Co-Diagnostics, Inc. has completed a Follow-on Equity Offering in the amount of $3.8476 million.Co-Diagnostics, Inc. has completed a Follow-on Equity Offering in the amount of $3.8476 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 9,619,000 Price\Range: $0.4 Discount Per Security: $0.028 Transaction Features: Registered Direct Offering
お知らせ • Sep 17+ 1 more updateCo-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $3.8476 million.Co-Diagnostics, Inc. has filed a Follow-on Equity Offering in the amount of $3.8476 million. Security Name: Common Stock Security Type: Common Stock Securities Offered: 9,619,000 Price\Range: $0.4 Transaction Features: Registered Direct Offering
お知らせ • Sep 11Co-Diagnostics, Inc. Performs Analysis of Chikungunya Co-Primers to Confirm Reactivity Against Known Virus StrainsCo-Diagnostics, Inc. announced that it has performed an in silico analysis of the primers sets used in its Co-Primers-based PCR tests for the detection of chikungunya virus (or "CHIKV"), showing a high homology against over 1,200 CHIKV sequences and confirming reactivity of the CHIKV primers against known recent strains of the virus. As of July, there have been nearly 250,000 cases and 90 deaths from CHIKV worldwide, primarily concentrated in South America, but also found in countries across Africa, Asia and Europe. An estimated 5.6 billion people currently live in at-risk areas across 119 countries as warming trends contribute to expanded regions for the mosquitoes that can carry CHIKV. Chikungunya imposes a significant economic burden, especially in low- and middle-income countries. Long-term consequences for the patient are also common, particularly joint pain that can be debilitating, with 40% of people contracting chronic chikungunya arthritis, leading to the pain lasting months or even years according to the Mayo Clinic. Less common complications include auto-immune disorders and chronic fatigue. The Co-Diagnostics Logix Smart®? ZDC Test received CE-marking regulatory clearance in 2019 to be sold as an in vitro diagnostic ("IVD") for the viruses that cause Zika, dengue and chikungunya. The test functions via the Company's patented Co-Primers technology and a single-step reverse transcriptase real-time PCR process to detect and differentiate between the viral RNA of Zika, dengue (all 4 serotypes), and chikungunya in blood drawn from patients. It is available for markets that accept CE-marking as valid regulatory clearance, pending local product registration requirements. Differentiating CHIKV cases from other infections with similar symptoms, such as dengue, helps physicians avoid administering certain pain and fever medications that can increase risk of bleeding and be life-threatening in patients with severe dengue infections. As an arbovirus spread by mosquitoes, accurate diagnosis is also vital to indicate to an infected patient that they should take additional precautions to limit contact with mosquitoes, to prevent further spread of the virus. Co-Dx also offers its Co-Primers-based environmental use only Vector Smart VZDC Test to mosquito abatement districts ("MADs"), as part of its suite of vector control tests used by around 30 MADs across approximately 20 U.S. states to identify pathogens such as Zika, dengue, chikungunya, West Nile virus, St. Louis encephalitis, and Eastern and Western equine encephalitis in mosquito pools. The Vector Smart VZDC Test CHIKV primer sets are the same as those used in the Logix Smart ZDC test. Co-Diagnostics Indian joint venture CoSara Diagnostics Pvt Ltd. received clearance in October 2021 by Indian authorities to manufacture and sell its SaraGene Dengue and Chikungunya Multiplex RT-PCR test as an IVD, which is also built on the Company's Co-Primers platform technology. This product is for export only and is not for sale in the United States.
お知らせ • Jul 31Co-Diagnostics, Inc. to Report Q2, 2025 Results on Aug 14, 2025Co-Diagnostics, Inc. announced that they will report Q2, 2025 results After-Market on Aug 14, 2025
お知らせ • Apr 29Co-Diagnostics, Inc. to Report Q1, 2025 Results on May 08, 2025Co-Diagnostics, Inc. announced that they will report Q1, 2025 results After-Market on May 08, 2025
お知らせ • Apr 16Co-Diagnostics, Inc., Annual General Meeting, May 28, 2025Co-Diagnostics, Inc., Annual General Meeting, May 28, 2025. Location: company s offices located at 2401 s. foothilldr, ste. d, slc, utah 84109, United States
お知らせ • Mar 13Co-Diagnostics, Inc. to Report Q4, 2024 Results on Mar 27, 2025Co-Diagnostics, Inc. announced that they will report Q4, 2024 results After-Market on Mar 27, 2025
お知らせ • Mar 07Co-Diagnostics, Inc. Wins Dismissal of Class Action LawsuitCo-Diagnostics, Inc. announced that on March 4, 2025, the Securities & Governance Litigation Team at BakerHostetler, the legal firm retained to represent the Company, won complete dismissal on summary judgment of a Section 10(b) securities class action that had been pending against the Company in the United States District Court for the District of Utah. On June 15, 2020, Plaintiff Gelt Trading Ltd. filed a securities class action against Co-Diagnostics, Inc. and certain of the Company's current and former directors and officers alleging violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.At issue was the Company's May 1, 2020, press release, which disclosed, among other things, that the Company's Logix Smart® COVID-19 test demonstrated "100% sensitivity and 100% specificity"—well-defined scientific metrics—across independent evaluations. Plaintiff alleged that the May 1 press release was false and/or misleading because it conveyed to investors that the Logix Smart test was "100% accurate" (i.e., perfect), allegedly causing the Company's stock price to be artificially inflated. Plaintiff alleged that this artificial inflation was removed, and investors suffered losses, when the Company's stock price dropped on May 15 following three disclosures that allegedly revealed the May 1 press release to be false ("Alleged Corrective Disclosures"). BakerHostetler was retained to replace prior counsel after the motion to dismiss was denied and the case was in the early phases of discovery. On summary judgment, BakerHostetler argued that Plaintiff could not establish any genuine issue of material fact supporting liability as to any element of its Section 10(b) claim—falsity, scienter, reliance, loss causation, or damages. BakerHostetler also argued that Plaintiff's experts' testimony—which related to clinical testing and loss causation—should be excluded on summary judgment under Daubert. On March 4, 2025, after oral argument, the Court granted Defendants' Daubert motion to exclude the testimony of Plaintiff's loss causation expert and granted summary judgment for Defendants, concluding that Plaintiff could not demonstrate loss causation. The Court held that none of the three Alleged Corrective Disclosures actually "corrected" the May 1 press release, either because they did not discuss the Company's Logix Smart test, or because the allegedly contradictory information was long known to the market and already baked into the Company's stock price. Accordingly, Plaintiff could not establish that the May 1 press release was the cause of Plaintiff's or the class's losses. Having reached this conclusion, the Court declined to address the other summary judgment arguments or Daubert motions. The Company regards this dismissal as a tremendous victory and is optimistic about its chances of prevailing in any appeal Plaintiff might file. The Company looks forward to putting the matter behind it, as it moves ahead with its mission of increasing the availability of high-quality molecular diagnostics on a global scale.
お知らせ • Feb 22Co-Diagnostics, Inc. Announces Intention to Submit Enhanced Version of COVID-19 Test to FDA for 510(k) ClearanceCo-Diagnostics, Inc. announced that, following a collaborative and informative dialogue with the Food and Drug Administration (FDA), the Company has withdrawn its 510(k) application to the FDA for its Co-Dx™ PCR COVID-19 Test on the PCR Pro™*, in favor of submitting an enhanced version of the test for 510(k) clearance. Co-Dx is pleased with the productive engagement with the FDA related to the initial regulatory submission and with the performance of the test in clinical evaluations, including performance data and functionality of the instrument. The decision by the Company to withdraw the submission was based on discussions with the FDA regarding the ability to detect a potential deterioration of one component of the test, related to shelf-life stability. Following dialogue with the FDA and exploring the various courses of action available, Co-Dx has determined that the best long-term solution would be to submit a version of the test that has been enhanced to address the matter raised in the 510(k) review process. The Company plans to submit the next iteration of the Co-Dx PCR COVID-19 test for 510(k) OTC clearance, following the collection of clinical evaluation data to support the new test's performance. A new submission also allows the Company to incorporate more recent Co-Dx PCR platform developments into the COVID-19 test, which Co-Dx believes will also help to create greater operational and manufacturing efficiencies, such as consolidating manufacturing processes to utilize the next generation of test kits and instruments across all tests on the at-home and point-of-care platform. The Company's primary objective is to execute a robust development and commercialization plan for the Co-Dx PCR platform, including ongoing innovations to the PCR Pro instrument. The Co-Dx PCR COVID-19 test is expected to be followed by additional tests for tuberculosis, upper-respiratory multiplex, and a multiplex HPV test, among others.
お知らせ • Jan 11Co-Diagnostics Receives a Notice from Nasdaq Listing Qualifications Department of the Nasdaq Stock MarketOn January 10, 2025, Co-Diagnostics, Inc. received a notice from Nasdaq Listing Qualifications department of the Nasdaq Stock Market LLC (“Nasdaq”) stating that the closing bid price of the Company’s common stock for the last 30 consecutive business days had closed below the minimum $1.00 per share required for continued listing under Listing Rule 5550(a)(2). The Company has a period of 180 calendar days, or until July 9, 2025 (the “Compliance Date”), to regain compliance with Listing Rule 5550(a)(2). To regain compliance, the bid price of the Company’s common stock must close at $1 or more for a minimum of ten consecutive business days before the Compliance Date. The Nasdaq notification letter does not result in the immediate delisting of the Company’s common stock, and the stock will continue to trade uninterrupted on the The Nasdaq Capital Market under the symbol “CODX”. If the Company does not regain compliance with Rule 5550(a)(2) by the Compliance Date, the Company may be eligible for additional time. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse stock split, if necessary. If the Company meets these requirements, the Staff will inform the Company that it has been granted an additional 180 calendar days. However, if it appears to the Staff that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, the Staff will provide notice that its securities will be subject to delisting.
お知らせ • Oct 26Co-Diagnostics, Inc. to Report Q3, 2024 Results on Nov 07, 2024Co-Diagnostics, Inc. announced that they will report Q3, 2024 results After-Market on Nov 07, 2024
お知らせ • Jul 25Co-Diagnostics, Inc. to Report Q2, 2024 Results on Aug 08, 2024Co-Diagnostics, Inc. announced that they will report Q2, 2024 results After-Market on Aug 08, 2024
お知らせ • Jul 17Co-Diagnostics, Inc., Annual General Meeting, Aug 29, 2024Co-Diagnostics, Inc., Annual General Meeting, Aug 29, 2024.
お知らせ • Jun 15Co-Diagnostics, Inc. Submits First FDA 510(k) Application for Co-Dx PCR Pro PlatformCo-Diagnostics, Inc. announced that the Company has completed its first U.S. Food and Drug Administration (FDA) application for 510(k) clearance for the Co-Dx PCR Pro instrument, and the Co-Dx PCR COVID-19 Test for over-the-counter (OTC) use. Co-Diagnostics completed the submission via the FDA's electronic Submissions Template And Resource (eSTAR) system, and have received the acknowledgement from the FDA that the 510(k) application was received. eSTAR serves as a comprehensive resource for medical device manufacturers to standardize and consolidate the necessary information and links needed for 510(k) submission preparation. The Co-Dx PCR platform has been designed to help close the access gap for infectious disease diagnosis by facilitating the widespread decentralization of gold-standard PCR diagnostics, which have historically only been found in high-complexity clinical laboratories. It consists of a compact and robust real-time PCR instrument operated at point-of-care or in at-home settings via an intuitive smartphone interface, with test cups powered by patented Co-Primers technology. The Company is also preparing to shortly pursue clearance for the Co-D x PCR COVID-19 test on the new instrument, to be used for point-of-care testing (POCT). Other diagnostics for the platform in varying stages of development or preparation for clinical evaluations include tests for tuberculosis, human papillomavirus, strep A, and a respiratory multiplex that detects influenza A and B, COVID-19 and RSV in a single test. The Co-Dx PCR platform (including the PCR Home, PCR Pro, mobile app, and all associated tests) is subject to review by the FDA and/or other regulatory bodies and is not yet available for sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are currently under review by the FDA.
お知らせ • Apr 27Co-Diagnostics, Inc. to Report Q1, 2024 Results on May 09, 2024Co-Diagnostics, Inc. announced that they will report Q1, 2024 results After-Market on May 09, 2024
お知らせ • Apr 04Co-Diagnostics, Inc. Appoints Executive AppointmentsCo-Diagnostics, Inc. appointed David Nielsen to be its Chief Operations Officer (COO), Christopher Thurston as its Chief Technology Officer (CTO), and Seth Egan as Chief Commercialization Officer (CCO). David Nielsen (COO) previously held the role of COO for Idaho Molecular, also acquired by Co-Dx in 2021, and has worked in concert with Advanced Conceptions and Co-Dx to help guide the development of the Company's new platform since that time. Including his time at Idaho Molecular, Mr. Nielsen has over 25 years of R&D technical and leadership experience, primarily at BioFire and BioFire Defense, filling various key roles which also included managing and coordinating the FilmArray diagnostic system throughout development and launch as the VP of Product Development. David earned both a Master of Science and M.B.A. from the University of Utah. As COO, David will leverage his experience to help lead Co-Dx's product development and manufacturing processes. Christopher Thurston's (CTO) distinguished career has included decades of experience serving as senior developer and architect of software platforms for companies including Ernst and Young, BioFire Defense, and BioMerieux, demonstrating his expertise in big-data solutions. Following his experience in executive positions at several startups, Christopher co-invented the Co-Dx PCR platform at Idaho Molecular, pursuing his passion for democratizing access to PCR diagnostics though technological innovation. Mr. Thurston's technology expertise will be significant in the advancement of Co-Dx's platform and tests. Seth Egan (CCO) has been with Co-Dx since its inception, leading the Company's sales, marketing and product commercialization efforts from the beginning, including managing the sales team as it sold approximately 35M Logix Smart® tests to centralized laboratories in more than 50 countries since the beginning of the pandemic. Mr. Egan has operated in many key capacities for the Company and continues to play an important role helping to oversee the relationship with CoSara Diagnostics, the Co-Dx joint venture in India. He holds a Bachelor of Science in Business Communications from Utah Valley University. Mr. Egan will play a crucial role as CCO in driving the Co-Dx PCR platform's commercialization efforts.
お知らせ • Mar 01Co-Diagnostics, Inc. to Report Q4, 2023 Results on Mar 14, 2024Co-Diagnostics, Inc. announced that they will report Q4, 2023 results at 4:00 PM, US Eastern Standard Time on Mar 14, 2024
お知らせ • Dec 27Co-Diagnostics, Inc. Completes Submission to FDA for Co-Dx PCR ProCo-Diagnostics, Inc. announced that it has submitted its Co-Dx™? PCR COVID-19 test with Co-Dx PCR Pro™? instrument for review by the U.S. Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). The submission includes the PCR Pro instrument, COVID-19 detection test, and mobile app, all designed for use in point-of-care and at-home settings. Tests run on the new platform use the Company's patented real-time polymerase chain reaction (PCR) Co-Primers™? technology. The Co-Dx COVID-19 test kit for the PCR Pro instrument included in the Company's FDA submission has been shown in clinical evaluations to detect the presence of COVID-19 in anterior nasal swab samples, with results displayed on the user's smartphone or mobile device in approximately 30 minutes. The menu of future tests that are currently in development for the new platform includes tuberculosis (TB) and human papillomavirus (HPV), as well as an upper respiratory multiplex panel that will detect influenza A/B, COVID-19, and respiratory syncytial virus (RSV) within a single sample. All three tests have also been the subject of grant support by notable funding bodies over the last half of this year.
お知らせ • Oct 27Co-Diagnostics, Inc. to Report Q3, 2023 Results on Nov 09, 2023Co-Diagnostics, Inc. announced that they will report Q3, 2023 results After-Market on Nov 09, 2023
お知らせ • Aug 30Co-Diagnostics, Inc. Appoints Ivory Chang as Chief Regulatory Affairs OfficerCo-Diagnostics, Inc. announced the appointment of Ivory Chang as the Company's Chief Regulatory Affairs Officer. Ms. Chang's in-depth regulatory affairs experience has included time spent with several notable names in the diagnostics industry, including Roche, Boston Scientific, BD Biosciences, Cepheid, Thermo Fisher Scientific, and more. Her background has involved regulatory and registration submissions to major regulatory bodies around the world for infectious disease, oncology, point-of-care, in vitro diagnostics (IVD), and software diagnostic products.
お知らせ • Jul 29Co-Diagnostics, Inc. to Report Q2, 2023 Results on Aug 10, 2023Co-Diagnostics, Inc. announced that they will report Q2, 2023 results After-Market on Aug 10, 2023
お知らせ • Jul 23Co-Diagnostics, Inc., Annual General Meeting, Aug 30, 2023Co-Diagnostics, Inc., Annual General Meeting, Aug 30, 2023, at 10:00 Mountain Standard Time. Agenda: To elect the two (2) Class II director nominees, each of whom are currently serving on company's board of directors, each to serve until the 2026 annual meeting of shareholders or until their successors are duly elected and qualified, or until his or her earlier death, resignation, or removal; to approve, on an advisory basis, the compensation of the Company’s named executive officers; to ratify the appointment of Tanner LLC as our independent registered public accounting firm for the fiscal year ending December 31, 2023; and to consider other business matters.
お知らせ • Jul 14Co-Diagnostics, Inc. Receives Funding for Co-Dx PCR Home Platform from NIH RADx Tech ProgramCo-Diagnostics, Inc. announced that it has been awarded $1.2 million in funding from the National Institutes of Health (NIH) as part of the Rapid Acceleration of Diagnostics (RADx®) Tech program for completion of its upcoming upper respiratory panel on the Company's Co-Dx PCR Home™ testing platform. Co-Diagnostics will utilize the funds from the RADx Tech award to complete development of its flu A/B, COVID-19, and RSV multiplex test, preparatory for that test to begin clinical trials on the Co-Dx PCR Home. The Co-Dx PCR Home is currently undergoing clinical evaluations in anticipation of its submission to the FDA and an initial product launch for a COVID-19 test. This project has been funded in part with federal funds from the National Institute of Biomedical Imaging (NIBIB), National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92023D00001. The Co-Dx PCR Home testing platform and its associated tests are subject to FDA review and are not available for sale.
お知らせ • May 06Co-Diagnostics, Inc. to Report Q1, 2023 Results on May 11, 2023Co-Diagnostics, Inc. announced that they will report Q1, 2023 results at 4:00 PM, US Eastern Standard Time on May 11, 2023
Valuation Update With 7 Day Price Move • Aug 18Investor sentiment deteriorated over the past weekAfter last week's 32% share price decline to €4.20, the stock trades at a forward P/E ratio of 54x. Average forward P/E is 36x in the Medical Equipment industry in Germany.
Reported Earnings • Aug 12Second quarter 2022 earnings released: US$0.083 loss per share (vs US$0.34 profit in 2Q 2021)Second quarter 2022 results: US$0.083 loss per share (down from US$0.34 profit in 2Q 2021). Revenue: US$5.02m (down 82% from 2Q 2021). Net loss: US$2.69m (down 127% from profit in 2Q 2021). Over the next year, revenue is forecast to grow 8.2%, compared to a 7.5% growth forecast for the industry in Germany.
Board Change • Jul 27High number of new and inexperienced directorsThere are 6 new directors who have joined the board in the last 3 years. The company's board is composed of: 6 new directors. 3 experienced directors. 1 highly experienced director. Chairman, CEO & President Dwight Egan is the most experienced director on the board, commencing their role in 2013. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors.
