Announcement • Feb 01
Biosynex SA (ENXTPA:ALBIO) entered into a definitive merger agreement to acquire Chembio Diagnostics, Inc. (NasdaqCM:CEMI) for $17.2 million. Biosynex SA (ENXTPA:ALBIO) entered into a definitive merger agreement to acquire Chembio Diagnostics, Inc. (NasdaqCM:CEMI) for $17.2 million on January 31, 2023. Under the terms of the merger agreement, Biosynex will initiate a tender offer to acquire all outstanding shares of Chembio. Biosynex will acquire Chembio for $0.45 per share, in an all-cash transaction valued at $17.2 million. Upon the successful completion of the tender offer, any remaining shares of common stock of Chembio will be canceled and converted into the right to receive the same $0.45 per share price payable in the tender offer. Biosynex will operate Chembio and its 100% owned German, Brazil and Malaysia subsidiaries as a wholly owned group. Upon completion, Chembio’s common stock will cease to be traded on The Nasdaq Stock Market LLC. Upon termination of the Merger Agreement under specified circumstances, Chembio must pay Biosynex a termination fee of $850,000 in cash.
The closing of the tender offer will be subject to certain conditions, including the tender of shares representing at least a majority of the total number of Chembio’s outstanding shares and other customary conditions. No vote of Chembio stockholders will be required in connection with the Merger. The terms of the merger agreement were unanimously approved by the Boards of Directors of Chembio and Biosynex, and and the Board of Directors has resolved to recommend to the stockholders of Chembio to accept the Offer and tender their Chembio shares. The transaction is expected to close in the first quarter of 2023.
Ernst & Young (EY) is acting as financial advisor and James Hu of White & Case LLP and Marc Petitier and Olivier Pâris of White & Case LLP (Paris) serving as legal counsels to Biosynex. Craig-Hallum Capital Group LLC is acting as financial advisor and Sean M. Jones of K&L Gates LLP is serving as legal counsel to Chembio. Craig-Hallum Capital Group LLC acted as fairness opinion provider to the board of Chembio. Announcement • Nov 29
Chembio Diagnostics, Inc. Announces FDA CLIA Waiver Submission for DPP HIV-Syphilis System Chembio Diagnostics, Inc. announced the submission to the U.S. Food and Drug Administration (FDA) for a Clinical Laboratory Improvement Amendments (CLIA) waiver for the DPP HIV-Syphilis System. Co-infection rates of HIV and syphilis are on the rise, according to the CDC, and individuals with an active syphilis infection have an estimated two- to five-fold increased risk of contracting HIV if exposed to that virus. The CDC has also reported that untreated syphilis in pregnant women who contracted the disease during the four years prior to delivery can lead to infection of the fetus in up to 80% of cases and may result in stillbirth or infant death in up to 40% of cases. Congenital syphilis is a preventable disease that could be significantly reduced through effective prenatal testing of women of childbearing age and treatment of infected pregnant women. Chembio's DPP HIV-Syphilis System assists clinicians in diagnosing both HIV and syphilis while patients are still under care at the testing location. The System is a multiplex, single-use, 15-minute test that is designed, in combination with Micro Reader analyzer, to simultaneously detect antibodies to HIV types 1 and 2 and Treponema pallidum, the bacteria that causes syphilis. The test uses a small, 10-microliter sample of fingerstick whole blood, venous whole blood, or plasma. Announcement • Oct 21
Chembio Diagnostics, Inc. to Report Q3, 2022 Results on Nov 03, 2022 Chembio Diagnostics, Inc. announced that they will report Q3, 2022 results at 4:00 PM, US Eastern Standard Time on Nov 03, 2022 Announcement • Oct 07
Chembio Diagnostics Receives Written Notice from Nasdaq As previously disclosed, on April 5, 2022, Chembio Diagnostics, Inc. received notification from the Listing Qualifications Department of The Nasdaq Stock Market, or Nasdaq, stating that the Company did not comply with the minimum $1.00 bid price requirement for continued listing set forth in Nasdaq Listing Rule 5550(a)(2) (the “Listing Rule”). In accordance with Nasdaq listing rules, the Company was afforded 180 calendar days (until October 3, 2022) to regain compliance with the Listing Rule. On October 4, 2022, the Company received written notice from Nasdaq (the “October Notice”) stating that, although the Company had not regained compliance with the minimum bid price requirement by October 3, 2022, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), the Company is eligible for an additional 180 calendar day period, or until April 3, 2023, to regain compliance with the Listing Rule. To regain compliance, the closing bid price of the Company’s common stock must meet or exceed $1.00 per share for a minimum of ten consecutive business days during this 180-day period. The October Notice has no effect on the listing or trading of the Company’s common stock at this time. The company intends to monitor the closing bid price of its common stock and consider available options to regain compliance with the Bid Price Requirement, which could include seeking to effect a reverse stock split. There can be no assurance that the company will be able to regain compliance with the Bid Price Requirement. Announcement • Jul 22
Chembio Diagnostics, Inc. to Report Q2, 2022 Results on Aug 04, 2022 Chembio Diagnostics, Inc. announced that they will report Q2, 2022 results After-Market on Aug 04, 2022 Announcement • May 26
Chembio Diagnostics, Inc. Elects Leslie Teso-Lichtman to its Board of Directors Chembio Diagnostics, Inc. announced the election of Leslie Teso-Lichtman to its Board of Directors at Chembio’s 2022 Annual Meeting of Stockholders. Ms. Teso-Lichtman serves as Senior Vice President and Chief Financial Officer of CereVasc, Inc., where she is responsible for the accounting, finance, and treasury functions, including forecasting and capital planning. Previously, Ms. Teso-Lichtman served as Senior Vice President of Finance and Treasurer for Roche Diagnostics Hematology from 2011 to 2014, following Roche’s acquisition of her former employer Constitutional Medical Investors, Inc. Ms. Teso-Lichtman worked on the integration plan for the new company and to achieve milestones in connection with the acquisition. Prior to her time at Constitutional Medical, Ms. Teso-Lichtman held the role of Vice President and Controller at Cytyc Corporation, which was acquired by Hologic, Inc. in 2007, where she was responsible for all finance and accounting activities, including completing three acquisitions. Announcement • Apr 22
Chembio Diagnostics, Inc. to Report Q1, 2022 Results on May 05, 2022 Chembio Diagnostics, Inc. announced that they will report Q1, 2022 results After-Market on May 05, 2022 Announcement • Apr 13
Chembio Gets Nasdaq Delisting Notice as Shares Sink Below $1 Chembio Diagnostics, Inc. has received a notice that it is out of compliance with Nasdaq Stock Market listing requirements. In a government filing, the company said it had been informed by Nasdaq that its share price had fallen below Nasdaq's $1-per-share minimum for 30 consecutive days. Under Nasdaq rules, Chembio has 180 days — until October 3, 2022 — to regain compliance, though an extension is possible. In the April 7, 2022 filing with the Securities and Exchange Commission, the company said it plans to "monitor" its stock price and will consider actions, including a reverse stock split, to regain compliance. Chembio President and Chief Executive Officer Richard Eberly said in an email that the company was unable to comment beyond the SEC filing. Announcement • Apr 12
Chembio Diagnostics, Inc., Annual General Meeting, May 24, 2022 Chembio Diagnostics, Inc., Annual General Meeting, May 24, 2022, at 10:00 US Eastern Standard Time. Agenda: Annual Meeting of Stockholders. Announcement • Apr 08
Chembio Diagnostics Receives Non-Compliance Letter from Nasdaq On April 5, 2022, Chembio Diagnostics, Inc. received a deficiency letter from the Listing Qualifications Department of The Nasdaq Stock Market, or Nasdaq, notifying the company that, for the last thirty consecutive business days, the bid price for shares of the company's common stock had closed below the $1.00 per share minimum bid price requirement for continued inclusion on the Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2), which the company refer to as the Bid Price Requirement. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), the company have been provided a period of 180 calendar days, or until October 3, 2022, to regain compliance with the Bid Price Requirement. If, at any time before October 3, 2022, the closing bid price for the company's common stock closes at or above $1.00 for a minimum of ten consecutive business days (which number days may be extended by Nasdaq in its discretion to generally no more than twenty consecutive business days), Nasdaq will notify the company that it have regained compliance with the Bid Price Requirement and the matter would be considered resolved. The deficiency letter also indicated that if the company do not regain compliance with the Bid Price Requirement by October 3, 2022, the company may be eligible for an additional 180 calendar days to regain compliance. To qualify, the company would need to meet the continued listing requirement for the 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 the company would need to provide written notice of the company's intention to cure the deficiency during the additional compliance period, by effecting a reverse stock split, if necessary. If the company meet these requirements, Nasdaq will inform the company that the company have been granted an additional 180 calendar days to regain compliance. Otherwise, including if it appears to the staff of Nasdaq that the company will not be able to cure the deficiency or if the company are not otherwise eligible, Nasdaq will notify the company that its common stock will be subject to delisting. At that time, the company may appeal Nasdaq’s delisting determination to a Nasdaq hearings panel. There can be no assurance that such appeal would be successful. The company intend to monitor the closing bid price of its common stock and consider available options to regain compliance with the Bid Price Requirement, which could include seeking to effect a reverse stock split. There can be no assurance that the company will be able to regain compliance with the Bid Price Requirement. Reported Earnings • Mar 05
Full year 2021 earnings: EPS and revenues exceed analyst expectations Full year 2021 results: US$1.40 loss per share (down from US$1.34 loss in FY 2020). Revenue: US$47.8m (up 47% from FY 2020). Net loss: US$33.9m (loss widened 33% from FY 2020). Revenue exceeded analyst estimates by 17%. Earnings per share (EPS) also surpassed analyst estimates by 34%. Over the next year, revenue is expected to shrink by 7.8% compared to a 11% growth forecast for the industry in the US. Over the last 3 years on average, earnings per share has fallen by 28% per year but the company’s share price has fallen by 49% per year, which means it is performing significantly worse than earnings. Announcement • Feb 18
Chembio Diagnostics, Inc. to Report Q4, 2021 Results on Mar 03, 2022 Chembio Diagnostics, Inc. announced that they will report Q4, 2021 results After-Market on Mar 03, 2022 Announcement • Dec 09
Chembio Diagnostics, Inc. Receives Notice from the U.S. Food and Drug Administration Require Additional Data Related to Clinical Laboratory Improvement Amendment On December 1, 2021, Chembio Diagnostics, Inc. received notice from the U.S. Food and Drug Administration, or FDA, that the FDA would require additional data related to Clinical Laboratory Improvement Amendment, or CLIA, waiver submission for the DPP HIV-Syphilis test system. contract, which refer to as the BARDA Agreement, dated December 2, 2020 with the Biomedical Advanced Research and Development Authority, or BARDA (part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response), expired in accordance with its terms on December 2, 2021. Under the BARDA Agreement, up to $12.7 million of awards were available from BARDA in order to assist in (a) developing, and requesting an EUA from the FDA for, the DPP Respiratory Panel and (b) performing the clinical trials for and submitting the DPP SARS-CoV-2 Antigen test system to the FDA, for 510(k) clearance. As of September 30, 2021 had earned a total of $9.6 million in grant income under the BARDA Agreement, and from October 1, 2021 through December 2, 2021 earned an additional $2.9 million of grant income under the BARDA Agreement. As a result, earned $12.5 million of the $12.7 million available under the BARDA Agreement, with the remaining $0.2 million having not been earned because it was contingent on receiving an emergency use authorization for the DPP Respiratory Panel by December 2, 2021. Announcement • Nov 30
Chembio Diagnostics Receives SAHPRA Approval for DPP SARS-CoV-2 Antigen Test Chembio Diagnostics, Inc. announced receipt on November 26, 2021, of South Africa Health Products Regulatory Authority (SAHPRA) approval for the DPP SARS-CoV-2 Antigen test, authorizing marketing and distribution of the test for use at the point-of-care by professional healthcare providers. The DPP SARS-CoV-2 Antigen test has been designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP SARS-CoV-2 Antigen test uses a minimally invasive nasal swab and is designed to be read visually or with a DPP Micro Reader 2 optical analyzer. Both the DPP SARS-CoV-2 Antigen test and the IgM/IgG Antibody test are authorized for import and distribution in South Africa by Chembios distributor, Patient Focus Africa, pursuant to licenses issued by SAHPRA. PFA is a World Health Organization accredited company for near patient testing, wellness, and professional point of care testing. PFA is partially owned by Discovery Health, and services both the public and private healthcare markets in the country. Reported Earnings • Nov 06
Third quarter 2021 earnings released: US$0.24 loss per share (vs US$0.28 loss in 3Q 2020) The company reported a solid third quarter result with improved revenues and control over costs, although losses increased. Third quarter 2021 results: Revenue: US$12.1m (up 17% from 3Q 2020). Net loss: US$6.37m (loss widened 15% from 3Q 2020). Over the last 3 years on average, earnings per share has fallen by 32% per year and the company’s share price has also fallen by 32% per year. Announcement • Sep 24
Chembio Diagnostics, Inc. Announces EUA Submission for DPP Respiratory Antigen Panel Chembio Diagnostics, Inc. announced the submission of an Emergency Use Authorization (EUA) application to the Food and Drug Administration (FDA) for the company’s DPP Respiratory Antigen Panel test system. The DPP Respiratory Antigen Panel test system is designed to provide simultaneous, discrete, and differential detection of Influenza A, Influenza B, and SARS-CoV-2 antigens from a single patient sample using a simple nasal swab. The test system is expected to provide results in approximately 20 minutes and be read on Chembio’s DPP Micro Reader analyzer. The system is intended to enable appropriate clinical management of patients with suspected respiratory infections and to assist in the containment of COVID-19 cases during the flu season. The DPP Respiratory Antigen Panel test system was developed with funds and support as part of a $12.7 million contract awarded by Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The contract also supports preparation of a submission to the FDA in pursuit of 510(k) clearance for the DPP SARS-CoV-2 Antigen test system. Chembio’s proprietary DPP technology platform provides high-quality, rapid diagnostic results in 15 to 20 minutes using a small drop of blood from the fingertip or alternative samples such as respiratory samples. Through advanced multiplexing, the DPP platform can detect up to eight, distinct test results from a single patient sample, delivering greater clinical value than other rapid tests. For certain applications, Chembio’s easy-to-use, highly portable, battery-operated DPP Micro Reader optical analyzer then reports accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still on-site. Objective results produced by the DPP Micro Reader reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests. Chembio’s portfolio of DPP-based point-of-care tests with FDA regulatory approvals include the DPP HIV-Syphilis System (PMA approved), DPP HIV 1/2 Assay (PMA approved and CLIA waived), DPP Zika IgM System (510(k)), and DPP Ebola Antigen System (EUA). Additionally, DPP-based tests have received regulatory approvals from the World Health Organization, CE-Mark, Agência Nacional de Vigilância Sanitária (ANVISA), and other global organizations, where they aid in the detection and diagnosis of several other critical diseases and conditions. All DPP tests are developed and manufactured in the United States and are the subject of a range of domestic and global patents and patents pending. Announcement • Aug 28
Chembio Launches Commercial Distribution of Third-Party COVID-19 Antigen Assay Chembio Diagnostics, Inc. announced its launch of commercial distribution of an FDA Emergency Use Authorized, patent pending, rapid point-of-care COVID-19 antigen test for use in decentralized and traditional testing settings. Product inventory is on-hand and immediately available for shipment to Chembio customers across the United States. The SCoV-2 Ag Detect Rapid Test, manufactured by InBios International, Inc., is a rapid immunoassay test authorized for use in laboratories with a CLIA waiver certification. It provides results in 20 minutes from a nasal swab and requires no instrumentation. The test can be used for both patients who are suspected of COVID-19 by their healthcare provider within 5 days of symptom onset and for asymptomatic serial testing. Reported Earnings • Aug 09
Second quarter 2021 earnings released: US$0.45 loss per share (vs US$0.42 loss in 2Q 2020) The company reported a solid second quarter result with improved revenues and control over costs, although losses increased. Second quarter 2021 results: Revenue: US$6.46m (up 26% from 2Q 2020). Net loss: US$9.06m (loss widened 16% from 2Q 2020). Over the last 3 years on average, earnings per share has fallen by 38% per year whereas the company’s share price has fallen by 36% per year. Major Estimate Revision • Aug 07
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast increased from US$36.1m to US$40.4m. EPS estimate unchanged from -US$0.92 at last update. Medical Equipment industry in the US expected to see average net income growth of 20% next year. Consensus price target of US$6.00 unchanged from last update. Share price rose 6.0% to US$3.01 over the past week. Reported Earnings • May 10
First quarter 2021 earnings released: US$0.22 loss per share (vs US$0.29 loss in 1Q 2020) The company reported a solid first quarter result with reduced losses, improved revenues and improved control over expenses. First quarter 2021 results: Revenue: US$8.72m (up 27% from 1Q 2020). Net loss: US$4.50m (loss narrowed 10.0% from 1Q 2020). Over the last 3 years on average, earnings per share has fallen by 40% per year but the company’s share price has only fallen by 27% per year, which means it has not declined as severely as earnings. Major Estimate Revision • May 09
Consensus forecasts updated The consensus outlook for 2021 has been updated. 2021 revenue forecast fell from US$36.7m to US$36.1m. 2021 losses expected to reduce from -US$1.15 to -US$1.01 per share. Medical Equipment industry in the US expected to see average net income growth of 28% next year. Consensus price target down from US$9.00 to US$8.00. Share price fell 14% to US$3.42 over the past week. Executive Departure • May 05
Independent Director has left the company On the 23rd of April, Mary Polan's tenure as Independent Director ended after 2.7 years in the role. We don't have any record of a personal shareholding under Mary's name. Mary is the only executive to leave the company over the last 12 months. Recent Insider Transactions Derivative • Mar 20
President exercised options and sold US$115k worth of stock On the 16th of March, Richard Eberly exercised options to acquire 78k shares at no cost and sold these for an average price of US$1.48 per share. This trade did not impact their existing holding. As of today, Richard currently holds no shares directly. This was the only transaction from an insider over the last 12 months. Reported Earnings • Mar 13
Full year 2020 earnings released: US$1.34 loss per share (vs US$0.81 loss in FY 2019) The company reported a poor full year result with increased losses, weaker revenues and weaker control over costs. Full year 2020 results: Revenue: US$32.5m (down 5.8% from FY 2019). Net loss: US$25.5m (loss widened 87% from FY 2019). Over the last 3 years on average, earnings per share has fallen by 40% per year but the company’s share price has only fallen by 18% per year, which means it has not declined as severely as earnings. Analyst Estimate Surprise Post Earnings • Mar 13
Revenue and earnings beat expectations Revenue exceeded analyst estimates by 16%. Earnings per share (EPS) also surpassed analyst estimates by 7.8%. Over the next year, revenue is forecast to grow 10%, compared to a 21% growth forecast for the Medical Equipment industry in the US. Announcement • Mar 09
Chembio Diagnostics Announces Board Changes Chembio Diagnostics, Inc. announced the appointment of David Bespalko to the Company’s Board of Directors, effective upon his election on March 4, 2021. Mr. Bespalko brings over 35 years of leadership experience in the global in vitro diagnostics market. Most recently he was Group Vice President, Global Commercial Operations Specialty Diagnostics Group at Thermo Fisher Scientific, which he joined in 2011 as President of Fisher Healthcare. During his tenure there, Mr. Bespalko held additional roles such as President of the Global Anatomical Pathology Division. Previously, Mr. Bespalko was Corporate Vice President, North America Commercial Operations at Beckman Coulter.
Also on March 4, 2021, Dr. Mary Lake Polan informed the Board of Directors that she would not stand for reelection to the Board at the Company’s 2021 Annual Meeting of Shareholders. Is New 90 Day High Low • Mar 05
New 90-day low: US$4.36 The company is down 33% from its price of US$6.46 on 04 December 2020. The American market is up 3.0% over the last 90 days, indicating the company underperformed over that time. It also underperformed the Medical Equipment industry, which is up 1.0% over the same period. Announcement • Feb 26
Chembio Diagnostics, Inc. to Report Q4, 2020 Results on Mar 11, 2021 Chembio Diagnostics, Inc. announced that they will report Q4, 2020 results After-Market on Mar 11, 2021 Is New 90 Day High Low • Feb 05
New 90-day high: US$7.58 The company is up 60% from its price of US$4.74 on 06 November 2020. The American market is up 13% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 8.0% over the same period. Announcement • Dec 19
Chembio Diagnostics, Inc. Appoints David Acheson, M.D. to Its Board of Directors Chembio Diagnostics, Inc. announced the appointment of David Acheson, M.D. to the Company’s Board of Directors.
Dr. David Acheson has served as the President and Chief Executive Officer of The Acheson Group since founding the global food safety consulting group in 2013. Previously he served as a Partner and Managing Director of Leavitt Partners, where he founded and managed the firm’s food safety services business. Price Target Changed • Dec 04
Price target raised to US$9.00 Up from US$6.00, the current price target is an average from 3 analysts. The new target price is 20% above the current share price of US$7.51. As of last close, the stock is up 88% over the past year. Announcement • Dec 03
Chembio Diagnostics Wins $12.7 Million Contract by BARDA for Development of Rapid DPP Respiratory Antigen Panel and 510(k) Submission of the Rapid DPP SARS-CoV-2 Antigen Test System Chembio Diagnostics, Inc. announced it has been awarded a contract from the Biomedical Advanced Research and Development Authority (BARDA), which is part of the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response. The contract will support the development and pursuit of U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for a rapid, multiplex DPP Respiratory Antigen Panel point-of-care test system using Chembio’s proprietary DPP technology for the upcoming flu season. The contract also supports preparation of a submission in pursuit of FDA 510(k) clearance for the rapid DPP SARS-CoV-2 Antigen test system that was recently submitted to the FDA for an EUA. The award totals $12,691,726. A second portion of the contract will support the verification, process validation, and production of clinical validation data to be included in a submission to the FDA for 510(k) clearance and CLIA-waiver for the DPP SARS-CoV-2 Antigen test system. This system consists of a DPP SARS-CoV-2 Antigen test cartridge and a DPP Micro Reader analyzer and is designed to use a minimally invasive nasal swab to detect SARS-CoV-2 viral antigens in only 20 minutes. The system was developed by Chembio and submitted to the FDA for an EUA on October 15, 2020, with support from BARDA under contract number 75A50120C00138. Is New 90 Day High Low • Dec 01
New 90-day high: US$5.74 The company is up 47% from its price of US$3.90 on 01 September 2020. The American market is up 7.0% over the last 90 days, indicating the company outperformed over that time. It also outperformed the Medical Equipment industry, which is up 3.0% over the same period. According to the Simply Wall St valuation model, the estimated intrinsic value of the company is per share. Major Estimate Revision • Nov 12
Analysts update estimates The 2020 consensus revenue estimate increased from US$21.1m to US$28.0m. Earning per share (EPS) estimate was further reduced from -US$1.17 to -US$1.24 for the same period. The Medical Equipment industry in the US is expected to see an average net income growth of 19% next year. The consensus price target of US$6.25 was unchanged from the last update. Share price is up 1.1% to US$4.48 over the past week. Reported Earnings • Nov 08
Third quarter 2020 earnings released: US$0.28 loss per share The company reported a soft third quarter result with increased losses and weaker control over expenses, although revenues were improved. Third quarter 2020 results: Revenue: US$10.3m (up 5.7% from 3Q 2019). Net loss: US$5.54m (loss widened 46% from 3Q 2019). Over the last 3 years on average, earnings per share has fallen by 35% per year but the company’s share price has only fallen by 11% per year, which means it has not declined as severely as earnings. Analyst Estimate Surprise Post Earnings • Nov 08
Revenue and earnings beat expectations Revenue exceeded analyst estimates by 162%. Earnings per share (EPS) also surpassed analyst estimates by 7.7%. Over the next year, revenue is forecast to grow 11%, compared to a 16% growth forecast for the Medical Equipment industry in the US. Announcement • Oct 16
Chembio Diagnostics, Inc. Submits EUA Application for DPP SARS-CoV-2 Antigen Test System Chembio Diagnostics, Inc. announced the submission of an application for Emergency Use Authorization (EUA) to the U.S. Food and Drug Administration (FDA) for the DPP SARS-CoV-2 Antigen test system, which has been designed to detect SARS-CoV-2 antigens in only 20 minutes. The DPP SARS-CoV-2 Antigen test system consists of a DPP SARS-CoV-2 Antigen test cartridge, a DPP Micro Reader optical analyzer and a minimally-invasive nasal swab. Announcement • Oct 03
Chembio Diagnostics, Inc Receives FDA Approval for DPP HIV-Syphilis System Chembio Diagnostics, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved the Premarket Approval (PMA) application for the DPP HIV-Syphilis System. The system includes the DPP HIV-Syphilis assay, a multiplex single-use test, and the DPP Micro Reader optical analyzer, and is being offered in the United States immediately. Co-infection rates of HIV and syphilis are on the rise and, according to the U.S. Centers for Disease Control and Prevention (CDC), individuals with an active syphilis infection have an estimated two-to-five-fold increased risk of contracting HIV if exposed to that virus. The CDC has also reported that untreated syphilis in pregnant women who acquired the disease during the four years before delivery can lead to infection of the fetus in up to 80% of cases and may result in stillbirth or infant death in up to 40% of cases. Congenital syphilis has increased by 185.3% from 2014 to 2018, consistent with the 165.4% increase in active syphilis infections among reproductive-aged women during the same period. Congenital syphilis is a preventable disease that could be significantly reduced through effective prenatal testing and treatment of infected pregnant women. Chembio’s DPP HIV-Syphilis System assists clinicians in diagnosing HIV or syphilis while patients are still at a POC setting. According to the U.S. Department of Health & Human Services, one in eight people living with HIV in the United States are unaware of their infection, and improving access to HIV testing can help more people learn their status so they can be connected to care and treatment. The CDC recommends that individuals at higher risk of HIV infection be tested at least annually. Announcement • Jul 24
Chembio Diagnostics, Inc. to Report Q2, 2020 Results on Aug 06, 2020 Chembio Diagnostics, Inc. announced that they will report Q2, 2020 results at 5:00 PM, Eastern Standard Time on Aug 06, 2020 