Ankündigung • May 09
Interpace Biosciences, Inc. Provides Revenue Guidance for the Full-Year 2025 Interpace Biosciences, Inc. provided revenue guidance for the full-year 2025. For the period, the company initiating revenue guidance of approximately $38 million. Ankündigung • Jan 10
Interpace Diagnostics® to No Longer Offer PancraGEN®, a Molecular Diagnostic Test That Assesses Pancreatic Cyst Cancer Risk Interpace Diagnostics® responded to the final Local Coverage Determination (LCD) of Genetic Testing for Oncology (L39365) issued by the Centers for Medicare & Medicaid Services (CMS). The new LCD establishes non-coverage for the Company’s widely used PancraGEN® test. PancraGEN is a DNA-based diagnostic molecular test. It uniquely assesses the risk of pancreatic cyst progression to cancer by integrating the results of first-line tests and procedures with molecular test results. It has been offered since 2013 and provides insight to physicians to aid their diagnosis of pancreatic cancer and help inform the optimal management of patients, including through the reduction of unnecessary surgeries. Because PancraGEN is primarily ordered for Medicare patients, Interpace will not be able to continue offering this test. Specimens for first-line fluid chemistry and PancraGEN testing will not be accepted after February 7, 2025. Ankündigung • Oct 17
Interpace Biosciences, Inc. announced that it has received $47 million in funding On October 16, 2024, Interpace Biosciences, Inc. closed the transaction. The transaction included participation from two investors. Ankündigung • Sep 23
Interpace Biosciences, Inc., Annual General Meeting, Nov 12, 2024 Interpace Biosciences, Inc., Annual General Meeting, Nov 12, 2024. Ankündigung • Jun 05
Interpace Diagnostics Announces New Data Analyzing Imbalance of Short Tandem Repeat Alleles for Pancreatic Cancer Detection Published as an ASCO 2024 Abstract Interpace Diagnostics, a subsidiary of Interpace Biosciences announced that new data demonstrating the application of advanced sequencing technologies in pancreatic cancer was published as an e-abstract as part of the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. Abstract e16359 highlights the evolving landscape of sequencing technologies for analyzing short tandem repeats (STRs) in pancreatic cancer detection. STRs, alternatively known as microsatellites, function as regulators of gene expression. STRs are prone to mutation with alterations correlated to pathogenicity--with allelic imbalance and microsatellite instability observed in diseases such as Huntington's disease, hereditary ataxia, and multiple cancers. While traditional methods such as capillary electrophoresis (CE) and Sanger sequencing have been the cornerstone for STR analysis, newer tools like second-generation short-read sequencing (NGS) and third-generation long-read sequencing (TGS) offer the potential for high-throughput scaling. Ankündigung • Dec 13
Robert Gorman Provides Notice to Interpace Biosciences, Inc. of His Resignation as A Director and as Chairman of the Board, Including as A Member of the Board’s Regulatory Compliance Committee On December 7, 2023, Robert Gorman, a Class II director designated by Ampersand 2018 Limited Partnership to the board of directors of Interpace Biosciences, Inc. provided notice to the Company of his resignation as a director and as Chairman of the Board, including as a member of the Board’s Regulatory Compliance Committee, effective immediately. Mr. Gorman’s notice was not the result of any disagreement with the Company on any matters relating to the Company’s operations, policies or practices. However, Mr. Gorman disagreed with the timing of the proposed change in his position from Executive Chairman to Chairman and the reduction in compensation thereunder. Ankündigung • Nov 18
Interpace Biosciences, Inc. Announces Resignation of Edward Chan as Class II Director On November 15, 2023, Edward Chan, a Class II director designated by 1315 Capital II, L.P. to the board of directors (the “Board”) of Interpace Biosciences, Inc. (the “Company”), provided notice to the Company of his resignation from the Board, effective immediately. Mr. Chan’s notice was not the result of any disagreement with the Company on any matters relating to the Company’s operations, policies or practices. Ankündigung • Sep 23
Interpace Biosciences, Inc., Annual General Meeting, Nov 14, 2023 Interpace Biosciences, Inc., Annual General Meeting, Nov 14, 2023, at 16:00 US Eastern Standard Time. Agenda: To consider election of two Class III director nominees named in the Proxy Statement, who will serve for a term of three years and until each such director’s successor is elected and qualified; to consider a non-binding advisory vote on a resolution approving the compensation of named executive officers; to consider a non-binding advisory vote on a resolution approving the compensation of named executive officers; to consider ratification of the appointment of EisnerAmper, LLP (EisnerAmper) as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2023; and to transact such other business as may properly come before the meeting or any adjournments or postponements thereof. Ankündigung • Aug 03
Interpace Biosciences, Inc. Appoints Christopher Mccarthy as Chief Financial Officer On July 24, 2023, the Board of Directors of Interpace Biosciences, Inc. appointed Christopher McCarthy, age 32,as Chief Financial Officer. Mr. McCarthy has served as the Company’s Principal Financial Officer since April 2023. Prior to serving as the Company’s Principal Financial Officer, Mr. McCarthy served as the Company’s Vice President of Finance and Enterprise Systems from August 2022 to April 2023, Senior Director of Operations Finance from August 2020 to August 2022 and the Company’s Senior Financial Analyst from June 2019 to August 2020. Prior to joining the Company, Mr. McCarthy served as a Senior Financial Systems Analyst at Simon & Schuster, Inc. from January 2016 to June 2019. Ankündigung • Jun 06
Interpace Biosciences, Inc. Expects to Stop Offering Pancragen Test Due to CMS Decision to End Reimbursement as of July 17, 2023 Interpace Biosciences, Inc. announced that the Centers for Medicare & Medicaid Services (CMS) issued the final Local Coverage Determination (LCD) of Genetic Testing for Oncology (L39365) which establishes non-co coverage for the Company's widely used PancraGEN®? test effective July 17, 2023. Commercially available in its current form since 2013, PancraGEN is a DNA-based molecular diagnostic test that uniquely assesses the risk of pancreatic cancerposed by pancreatic cysts and is used to rule-in and rule-out (risk-stratify) the disease. The important information provided by PancraGEN helps support the differential diagnosis of pancreatic cancer by integrating the results of first-line tests and procedures with molecular test results. This insight aids physicians in their diagnosis of pancreatic cancer and helps inform the optimal management of patients, including through the reduction of unnecessary surgeries. Because of the high mortality rate of pancreatic cancer, surgery is often performed as a cautious approach to treat suspicious pancreatic cysts. Yet, studies have shown that 60% to 80% of surgeries reveal indolent cysts that did not necessarily require surgery. The surgery is also high-cost and subject to mortality and significant morbidity. First-line diagnostic tests and procedures--imaging, fluid chemistry (CEA, glucose, amylase), cytology, and patient risk factors-- do not always provide a complete picture of malignancy risk. According to Interpace, the integrated molecular pathology approach provided by PancraGEN is an important tool that has helped to reduce the number of unnecessary surgeries for suspicious cysts. He points out the test is currently still available and will remain in place until it is no longer economically feasible to offer following the elimination of reimbursement. Ankündigung • Sep 21
Interpace Biosciences, Inc., Annual General Meeting, Nov 10, 2022 Interpace Biosciences, Inc., Annual General Meeting, Nov 10, 2022, at 16:00 US Eastern Standard Time. Agenda: To consider Election of one Class I director nominee named in the Proxy Statement, who will serve for a term of three years and until such director’s successor is elected and qualified; to consider Approval of an amendment to the Company’s 2019 Equity Incentive Plan to increase the number of authorized shares of common stock reserved for issuance by 1,000,000 shares; to consider Approval of an amendment to the Company’s Employee Stock Purchase Plan to increase the number of authorized shares of common stock reserved for issuance by 1,000,000 shares; and to transact such other business as may properly come before the meeting or any adjournments or postponements thereof. Ankündigung • Sep 02
Interpace Biosciences, Inc. Announces New Clinical Validation Data Interpace Biosciences, Inc. announced new clinical validation data for their thyroid cancer test platform which is comprised of a mutation panel (ThyGeNEXT®) and a microRNA (miRNA) risk classifier. The new data demonstrates that the addition of miRNA pairwise expression profiling (ThyraMIR®v2) provides clinically and statistically superior risk stratification of indeterminate thyroid nodules (ITN) beyond that of the algorithmic classification analysis provided by the original ThyraMIR® assay. ThyraMIRv2 was developed and validated in a fully blinded cohort (n=197) from a previous retrospective validation study. The new data analysis revealed improvement in the number of true negative results and reduction of false positive results with a subsequent improvement in the specificity and PPV at positive threshold, while preserving a high sensitivity and NPV. The ROC AUC increased from 0.85 to 0.97 (p<0.001), and the diagnostic accuracy at the positive threshold increased significantly (p<0.05) from 83% (CI, 76-88) to 93% (CI, 89-96). ThyraMIRv2 optimized risk stratification of nodules with RAS-like (weak driver) mutations, minimally invasive follicular carcinomas, low-grade PTC, and Hürthle cell predominant nodules—providing significant improvement in test accuracy and the higher NPV and PPV of commercially available tests. Ankündigung • Sep 01
Flagship Biosciences, Inc. completed the acquisition of Interpace Pharma Solutions from Interpace Biosciences, Inc. (OTCPK:IDXG). Flagship Biosciences, Inc. acquired Interpace Pharma Solutions from Interpace Biosciences, Inc. (OTCPK:IDXG) on August 31, 2022. Interpace Biosciences will use the proceeds from the transaction for working capital requirements and investments to help drive the growth of its molecular diagnostics business.Flagship Biosciences, Inc. completed the acquisition of Interpace Pharma Solutions from Interpace Biosciences, Inc. (OTCPK:IDXG) on August 31, 2022. Ankündigung • Aug 17
Interpace Biosciences, Inc. Announces New Clinical Validation Data for Thyroid Cancer Test Platform Published Online Within Thyroid®, the Leading Peer-Reviewed Journal for Original Research on Thyroid Cancer Interpace Biosciences, Inc. announced new clinical validation data for thyroid cancer test platform (ThyGeNEXT® + ThyraMIR®) was published online within THYROID®, the leading peer-reviewed journal for original research on thyroid cancer. These new data demonstrated that the addition of microRNA pairwise expression profiling (ThyraMIR®v2) provided clinically and statistically superior risk stratification of indeterminate thyroid nodules beyond that of the algorithmic classification analysis provided by the original ThyraMIR® assay. Additionally, the Company will be launching Point2Glucose™—a new pancreatic cyst fluid tumor marker diagnostic test offering that requires a very low volume of cyst fluid (0.2ml). Intracystic glucose is considered to be more accurate than the current diagnostic standard, carcinoembryonic antigen (CEA). Point2Glucose™ has been validated specifically for use in pancreatic cyst fluid and has been shown to be able to provide an accurate result even with viscous or bloody samples. Ankündigung • Feb 24
Interpace Biosciences, Inc Announces Update of Previously Announced CMS Billing Policy Impacting its Thyroid Tests Interpace Biosciences, Inc. announced that the National Correct Coding Initiative (NCCI) program issued a response on behalf of the Centers for Medicare & Medicaid Services (CMS) stating that the previously announced billing policy reimbursement for its ThyGeNEXT (O245U) and ThyraMIR (oo18U) tests, disclosed by it in a press release dated January 28, 2022, has been changed retroactive to January 1, 2022. As a result, the Company will continue billing for both tests according to its Laboratory Coverage Determination (LCD) as originally set by Novitas. According to CMS, this updated policy will be posted on its website and will be included in the July 1, 2022 edit file. Ankündigung • Jan 28
Interpace Biosciences Announces Appointment of Vijay Aggarwa as New Director to the Board of Directors Interpace Biosciences, Inc. announce that Vijay Aggarwal, Ph.D., has been appointed to the Interpace Board of Directors effective February 1, 2022. Dr. Aggarwal replaces Eric B. Lev, both designees of Ampersand 2018 Limited Partnership, a Series B Preferred stockholder of the Company. Dr. Aggarwal has over thirty years of experience in both pharmaceutical services and clinical diagnostics. In addition to serving as Managing Partner of The Channel Group, Dr. Aggarwal provides strategic advisory services to companies with operations or investments in the clinical diagnostics, molecular diagnostic and anatomic pathology sectors. Dr. Aggarwal has previously served as CEO of Vaxigenix, a pharmaceutical company developing vaccine treatments for colorectal cancer, as President and CEO of Aureon Laboratories, Inc., a predictive pathology company offering advanced tissue analysis services to practicing physicians and the pharmaceutical industry, as President of AAI Development Services, Inc., a global contract research and development services company serving the pharmaceutical and biotech industries, and as President of Quest Diagnostic Ventures, where he had responsibility for new technology, new business models, clinical trials testing, and direct–to-consumer strategies. Earlier in his career, Dr. Aggarwal held many positions with SmithKline Beecham Clinical Laboratories (“SBCL”), the clinical laboratory operations of SmithKline Beecham plc, including direct responsibility for all of SBCL’s U.S.-based laboratories as Executive Vice President of Laboratories, responsibility for reimbursement as Vice President of Managed Care and several General Management assignments. Ankündigung • Jan 14
Interpace Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $27.930299 million. Interpace Biosciences, Inc. has completed a Follow-on Equity Offering in the amount of $27.930299 million.
Security Name: Common Stock
Security Type: Common Stock
Securities Offered: 4,200,045
Price\Range: $6.65
Discount Per Security: $0.15
Transaction Features: Rights Offering Ankündigung • Aug 12
Interpace Biosciences, Inc. Provides Revenue Guidance for the Full Year 2021 Interpace Biosciences, Inc. provided revenue guidance for the full year 2021. The company announced that on track to exceed full year 2021 revenue growth of 35%. Ankündigung • May 13
Interpace Biosciences, Inc. Provides Revenue Guidance Second Quarter of Fiscal 2021 Interpace Biosciences, Inc. is providing second quarter fiscal 2021 revenue guidance north of $11 million. Ankündigung • Apr 03
Interpace Biosciences, Inc. announced delayed annual 10-K filing On 04/01/2021, Interpace Biosciences, Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. Ankündigung • Apr 01
Interpace Biosciences, Inc. Provides Full Year Revenue Guidance for 2021 Interpace Biosciences, Inc. providing full year revenue guidance in the range of $38 million to $40 million before 2021 year-end. Ankündigung • Mar 18
DiamiR, LLC entered into a definitive agreement to acquire a CLIA certified laboratory in New Haven of Interpace Biosciences, Inc. (OTCPK:IDXG). DiamiR, LLC entered into a definitive agreement to acquire a CLIA certified laboratory in New Haven of Interpace Biosciences, Inc. (OTCPK:IDXG) on March 17, 2021. Subject to specific terms and conditions of the agreement being met, it is anticipated that the transaction will close by the end of April, 2021. Ankündigung • Feb 27
Interpace Biosciences, Inc. Announces Contract for Thyroid Testing with Blue Cross Blue Shield of Illinois Interpace Biosciences, Inc. announced that Blue Cross Blue Shield of Illinois, owned by Health Care Services Corporation (HCSC) and the largest health plan in Illinois with greater than 8 million covered lives, has entered into an agreement to provide both coverage and in-network status for Interpace’s molecular combination thyroid tests, ThyGeNEXT and ThyraMIR. The agreement is effective February 25, 2021. ThyGeNEXT utilizes next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer, as well as Medullary Thyroid Carcinoma. ThyraMIR® is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR measures the expression of 10 microRNAs. Both ThyGeNEXT and ThyraMIR are covered by Medicare and most commercial insurers, with more than 280 million members covered. ThyGeNEXT® and ThyraMIR® reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis. Ankündigung • Feb 26
Interpace Biosciences to Be Delisted from Nasdaq and to Commence Trading on OTCQX As previously disclosed in Interpace Biosciences, Inc.’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 17, 2021, the Company received a notification from The Nasdaq Stock Market (“Nasdaq”) indicating that, as a result of the Company’s previously disclosed noncompliance with Nasdaq Listing Rules 5550(b), Nasdaq has determined to delist the Company’s common stock from the Nasdaq Capital Market and, accordingly, will suspend trading in the Company’s common stock effective at the open of business on February 25, 2021. The Company expects that Nasdaq will also file a Form 25-NSE with the Commission to delist the Company from the Nasdaq Capital Market. On February 24, 2021, the Company was approved to have its common stock quoted on the OTCQX Best Market tier of the OTC Markets Group Inc. (the “OTCQX”), an electronic quotation service operated by OTC Markets Group Inc. The Company expects that trading of the Company’s common stock will commence on OTCQX at the open of business on February 25, 2021 under the trading symbol IDXG. Ankündigung • Feb 18
Interpace Biosciences Announces Impending Delisting from Nasdaq On February 17, 2021 Interpace Biosciences, Inc. announced that on February 16, 2020 it had received notification from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) that the Staff has determined to delist the Company’s securities from Nasdaq. This determination was due to the Company’s extended period of non-compliance with the minimum $2,500,000 stockholders’ equity requirement for continued listing set forth in listing Rule 5550(b) and the Company’s failure to timely execute on its plan to comply. Unless the Company requests an appeal of this determination, trading of the Company’s common stock will be suspended at the opening of business on February 25, 2021. The Company has applied to have its common stock qualified to trade on the OTCQX® Best Market (“OTCQX”). The Staff reached its decision to delist the Company’s common stock based upon the Company’s continued non-compliance with Nasdaq Listing Rules as follows: On October 21, 2020, Staff notified the Company that it did not comply with the minimum $2,500,000 stockholders’ equity requirement for continued listing set forth in Nasdaq Listing Rule 5550(b) (the “Rule”). According to the Form 10-Q for the period ended June 30, 2020 (the “Form 10-Q”), the Company’s stockholders’ equity was $1,693,000. In addition, the Company did not meet any of the alternatives under the Rule. Up until the filing of the Form 10-Q for the period ended June 30, 2020, the Company reported a compliant stockholders’ equity number in its periodic reports. However, on January 19, 2021, the Company filed the Forms 10-Q/A for the periods ended March 31, 2020 and June 30, 2020 and Form 10-K/A for the fiscal year ended December 31, 2019. According to the amended filings, the Company reported stockholders’ deficit of approximately ($10.9) million and ($16.1) million for the periods ended March 31, 2020 and June 30, 2020 respectively. Additionally, the Company reported stockholders’ deficit of approximately ($4.5) million for the fiscal year ended December 31, 2019. As a result, Nasdaq determined that the Company has failed to comply with the continued listing requirements for approximately one year. The Company submitted a plan of compliance to regain compliance with the Rule but was not in a position to complete execution of such plan by February 15, 2021. The Company is determining whether to appeal the determination. In the absence of such appeal trading of the Company’s common stock on NASDAQ will be suspended at the opening of business on February 25, 2021, and a Form 25-NSE will be filed with the Securities and Exchange Commission (the “SEC”), which will remove the Company’s securities from listing and registration on Nasdaq. Ankündigung • Feb 06
Interpace Biosciences, Inc. Announces CFO Changes On January 31, 2021, Fred Knechtel, the Chief Financial Officer, Treasurer, and Secretary of the Company, left the employ of Interpace Biosciences, Inc. (the “Company”) and on February 1, 2021 Thomas J. Freeburg, age 53, who has served as the Company’s Chief Accounting Officer since October 2017, was appointed as the Company’s successor Chief Financial Officer, Treasurer, and Secretary. Ankündigung • Feb 05
Interpace Biosciences, Inc. Announces Executive Changes On January 31, 2021, Fred Knechtel, the Chief Financial Officer, Treasurer, and Secretary of the Company, left the employ of Interpace Biosciences, Inc. and on February 1, 2021 Thomas J. Freeburg, age 53, who has served as the Company's Chief Accounting Officer since October 2017, was appointed as the Company's successor Chief Financial Officer, Treasurer, and Secretary. Prior to serving as the Company's Chief Accounting Officer, Mr. Freeburg was a Managing Member of Cambridge Financial Consultants LLC from 2014 to September 2017. Ankündigung • Feb 02
Interpace Biosciences Announces License Agreement with Rutgers University and Mass General Hospital Interpace Biosciences, Inc. announced that it has executed a license agreement with Rutgers, The State University of New Jersey, and Massachusetts General Hospital for a novel monoclonal antibody platform, Das-1, used in the risk assessment of pancreatic cysts. Although some cysts may have no cancerous potential at all, other cysts carry up to a 48% chance of harboring invasive cancer, and surgery to remove them is often complex. Therefore, there is a need to develop additional tools to identify which pancreatic cysts may develop into cancer and which ones will not. In a recent, national multicenter study of patients undergoing surgery for pancreatic cysts, the Das-1 antibody was able to accurately identify pancreatic cysts likely to become cancerous with high sensitivity and high specificity in comparison to current clinical guidelines (Das, K et al, “Cross Validation of the Monoclonal Antibody Das-1 in Identification of High-Risk Mucinous Pancreatic Cystic Lesion”. Das-1 is gaining recognition among experts in the GI community as evidenced by its inclusion as a component in the Pancreatic Cyst Biomarker Alliance sponsored in part by the National Cancer Institute. The license gives Interpace exclusive commercial rights to this patented technology. The Company’s product, PancraGEN®, was designed to provide risk assessment for pancreatic cysts using both molecular and clinical features and has been performed on more than 40,000 pancreatic cysts. This new biomarker will provide additional information regarding cancer risk to further facilitate personalized patient management. Ankündigung • Jan 29
Interpace Biosciences, Inc. Announces Contract for Thyroid Testing with Blue Cross Blue Shield of Florida Interpace Biosciences, Inc. announced that the company’s Diagnostics group has entered in to a contract with Blue Cross Blue Shield of Florida. As part of the Agreement, Interpace’s ThyGeNEXT® and ThyraMIR® tests for indeterminate thyroid nodules will be adjudicated as in-network lab services for its 5 million members effective January 1, 2021. The plan agreed to cover the tests under its medical policy in 2018. Ankündigung • Jan 21
Interpace Biosciences, Inc. to Report Q3, 2020 Results on Jan 21, 2021 Interpace Biosciences, Inc. announced that they will report Q3, 2020 results After-Market on Jan 21, 2021 Ankündigung • Nov 21
Interpace Biosciences Receives Nasdaq Deficiency Notice Interpace Biosciences, Inc. on November 18, 2020 received notice from the Listing Qualifications Staff (the “Staff”) of The Nasdaq Stock Market LLC (“Nasdaq”) indicating that, due to the delay in the filing of the Company’s Form 10-Q for the quarterly period ended September 30, 2020 (the “Form 10-Q”) with the Securities and Exchange Commission (the “SEC”), Interpace does not currently satisfy Nasdaq Listing Rule 5250(c)(1), which requires the timely filing of all periodic reports with the SEC. The deficiency has no immediate effect on the listing or trading of the Company’s common stock on Nasdaq. In accordance with the Nasdaq Listing Rules, Interpace was provided 60 calendar days to submit its plan to evidence compliance with the filing requirement and the Staff has the discretion to grant Interpace up to 180 calendar days from the SEC deadline to file the Form 10-Q based on that plan. The Company is diligently working to file the Form 10-Q within the timeline prescribed by Nasdaq. Ankündigung • Nov 18
Interpace Biosciences, Inc. announced delayed 10-Q filing On 11/17/2020, Interpace Biosciences, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. Ankündigung • Oct 27
Interpace Biosciences, Inc. Announces Results of Seminal Clinical Validation Study for Thyroid Assays Interpace Biosciences, Inc. announced that the study entitled 'Multiplatform molecular test performance in indeterminate thyroid nodules' was published on-line in the peer-reviewed journal, Diagnostic Cytopathology. This paper represents the culmination of a multi-center, blinded clinical validation study in which gold standard unanimous histopathology consensus diagnosis was utilized. The study results demonstrate that ThyGeNEXT® + ThyraMIR® combination testing yield the highest positive predictive value (PPV) and similar negative predictive value (NPV) in comparison to other marketed tests for the same indication. Approximately 25% of thyroid nodule fine needle aspirates (FNAs) have cytology that is indeterminate for malignant disease. Ancillary multiplatform testing with ThyGeNEXT® and ThyraMIR® assists in the accurate risk stratification of these FNAs, ultimately helping to distinguish patients who are more likely to benefit from conservative management from those who are more likely to benefit from surgical intervention. The published manuscript is the first to report the performance characteristics of combination ThyGeNEXT® and ThyraMIR® testing in a blinded multicenter study. ThyGeNEXT® is the company’s most recent next generation sequencing based test that was expanded from its original version (ThyGenX®) to include markers that have targeted therapies and those that can identify aggressive forms of thyroid cancer. The study demonstrates that combination testing with ThyGeNEXT® and ThyraMIR® has both high sensitivity (95%) and high specificity (90%) for identifying disease. It also highlights the important role that ThyraMIR®—the company’s proprietary microRNA risk classifier—can play in helping to identify malignancy in nodules where single platform mutation panels commonly detect mutations that by themselves have suboptimal PPV for malignancy. ThyGeNEXT® is Interpace’s most recent next generation sequencing test that was expanded from its original version (ThyGenX®) to include markers that have targeted therapies and those that can identify aggressive forms of thyroid cancer. ThyGeNEXT® utilizes next-generation sequencing (NGS) to identify more than 100 genetic alterations associated with papillary and follicular thyroid carcinomas, the two most common forms of thyroid cancer, as well as Medullary Thyroid Carcinoma. ThyraMIR® is the first microRNA gene expression classifier. MicroRNAs are small, non-coding RNAs that bind to messenger RNA and regulate expression of genes involved in human cancers, including every subtype of thyroid cancer. ThyraMIR® measures the expression of 10 microRNAs. Both ThyGeNEXT® and ThyraMIR® are covered by Medicare and most Commercial insurers. According to the American Thyroid Association, approximately 20% of the 525,000 thyroid fine needle aspirations (FNAs) performed on an annual basis in the U.S. are indeterminate for malignancy based on standard cytological evaluation, and thus are candidates for ThyGeNEXT® and ThyraMIR®. ThyGeNEXT® and ThyraMIR® reflex testing yields high predictive value in determining the presence and absence of cancer in thyroid nodules. The combination of both tests can improve risk stratification and surgical decision-making when standard cytopathology does not provide a clear diagnosis. Ankündigung • Aug 21
Interpace Biosciences Receives Notice from Listing Qualifications Staff on Nasdaq On August 18, 2020, Interpace Biosciences, Inc. (NasdaqCM:IDXG) received a notice from the Listing Qualifications Staff (the "Staff") of The Nasdaq Stock Market LLC indicating that, due to the delay in the filing of the Company's Form 10-Q for the quarterly period ended June 30, 2020 (the "Form 10-Q") with the Securities and Exchange Commission, Interpace does not currently satisfy Nasdaq Listing Rule 5250(c)(1), which requires the timely filing of all periodic reports with the SEC. The deficiency has no immediate effect on the listing or trading of the Company's common stock on Nasdaq. In accordance with the Nasdaq Listing Rules, Interpace was provided 60 calendar days to submit its plan to evidence compliance with the filing requirement and the Staff has the discretion to grant Interpace up to 180 calendar days from the SEC deadline to file the Form 10-Q based on that plan. The Company is diligently working to file the Form 10-Q within the timeline prescribed by Nasdaq. On August 20, 2020, the Company issued a press release announcing its receipt of the Notice. The full text of the press release is set forth as Exhibit 99.1 attached hereto. The information in Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the "Exchange Act"), or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any registration statement or other document filed under the Securities Act of 1933, as amended, or the Exchange Act, except as otherwise stated in such filing. Ankündigung • Aug 15
Interpace Biosciences, Inc. announced delayed 10-Q filing On 08/14/2020, Interpace Biosciences, Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC.