Interpace Biosciences Announces New Real-world Data; Presented at the American Thyroid Association 2022 Annual Meeting

Rhea-AI Summary

Interpace Biosciences (OTCQX: IDXG) announced new clinical utility data for its ThyGeNEXT® + ThyraMIR®v2 test platform. The findings, presented at the American Thyroid Association (ATA) 2022 Annual Meeting, demonstrate the platform's effectiveness in assessing malignancy risk in indeterminate thyroid nodules (ITN). Key results include improved accuracy, a decreased false-positive rate, and a 70% benign call rate, potentially reducing unnecessary surgeries for patients. CEO Tom Burnell reaffirmed the company's commitment to personalized medicine.

Positive

• Increased accuracy of malignancy risk assessment for thyroid nodules.
• Decreased false-positive rate enhances test reliability.
• 70% benign call rate allows more patients to avoid unnecessary surgeries.

Negative

• Dependence on third-party reimbursements may pose financial risks.
• Potential for operational disruptions due to the COVID-19 pandemic.
• History of operating losses raises concerns about the company's financial stability.

PARSIPPANY, NJ, Oct. 20, 2022 (GLOBE NEWSWIRE) -- Interpace Biosciences, Inc. (“Interpace” or the “Company”) (OTCQX: IDXG), a fully integrated commercial company that provides clinically relevant molecular diagnostic tests and pathology services for improved patient diagnosis and management, today announced new real-world clinical utility data for their ThyGeNEXT^® + ThyraMIR^®v2 combination test platform to assess the malignancy risk of indeterminate thyroid nodules (ITN). The findings are from an independent study and were shared today in a highlighted poster presentation during the American Thyroid Association (ATA) 2022 Annual Meeting (Poster #119). The poster can also be viewed at www.thyroiddx.com/poster.

Clinical utility was determined within a prospectively collected, consecutive, real-world clinical cohort utilizing the ThyGeNEXT oncogene mutation panel and an earlier version of the Company’s microRNA (miRNA) risk classifier, ThyraMIR^®. A secondary, retrospective analysis was also performed with ThyraMIRv2, the Company’s new miRNA pairwise expression profiler.

The data supports that both versions of the test platform accurately risk-stratified ITNs. Additionally, a blinded analysis of pairwise miRNA expression profiling demonstrated improved accuracy from the original testing platform. A decrease in the false-positive rate and a high Benign Call Rate (BCR) of 70% were also demonstrated in this study, thereby allowing more patients to avoid potentially unnecessary surgery.

Dr. Syd Finkelstein, Chief Scientific Officer of Interpace Diagnostics, LLC added, “We are pleased that these independent clinical utility data further support the very strong effectiveness of miRNA pairwise expression profiling in risk-stratifying indeterminate thyroid nodules”.

Further commenting, President and CEO of Interpace Biosciences, Tom Burnell, PhD, stated “We remain committed to providing high-value molecular diagnostic tests that aid in the diagnosis and prognosis of thyroid and other cancers. This commitment fully aligns to the Interpace corporate goal of improving healthcare by enabling personalized medicine.”

About Interpace Biosciences

Interpace Biosciences is an emerging leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.

Clinical services, through Interpace Diagnostics, provide clinically useful molecular diagnostic tests and bioinformatics and pathology services for evaluating risk of cancer by leveraging the latest technology in personalized medicine for improved patient diagnosis and management. Interpace has five commercialized molecular tests and one test in a clinical evaluation program (CEP): PancraGEN^® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; PanDNA^®, a “molecular only” version of PancraGEN that provides physicians a snapshot of a limited number of factors; ThyGeNEXT^® for the diagnosis of thyroid cancer from thyroid nodules utilizing a next-generation sequencing assay; ThyraMIR^®v2, used in combination with ThyGeNEXT^®, for the diagnosis of thyroid cancer utilizing a proprietary microRNA pairwise expression profiler along with algorithmic classification; and RespriDX^®, that differentiates lung cancer of primary versus metastatic origin. In addition, BarreGEN^®, a molecular-based assay that helps resolve the risk of progression of Barrett’s Esophagus to esophageal cancer, is currently in a CEP, whereby we gather information from physicians using BarreGEN to assist us in gathering clinical evidence relative to the safety and performance of the test and also providing data that will potentially support payer reimbursement.

For more information, please visit Interpace Biosciences’ website at www.interpace.com.

Forward-looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934, and the Private Securities Litigation Reform Act of 1995, relating to the Company's future financial and operating performance. The Company has attempted to identify forward-looking statements by terminology including "believes," "estimates," "anticipates," "expects," "plans," "projects," "intends," "potential," "may," "could," "might," "will," "should," "approximately" or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are based on current expectations, assumptions, and uncertainties involving judgments about, among other things, future economic, competitive and market conditions, and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company's control. These statements also involve known and unknown risks, uncertainties, and other factors that may cause the Company’s actual results to be materially different from those expressed or implied by any forward-looking statements, including, but not limited to, the reimbursement of the Company’s tests being subject to review by CMS, the adverse impact of the COVID19 pandemic on the Company’s operations and revenues, the substantial doubt about the Company’s ability to continue as a going concern, the possibility that the Company’s estimates of future revenue, cash flows, and adjusted EBITDA may prove to be materially inaccurate, the Company’s history of operating losses, the Company’s ability to adequately finance its business and seek alternative sources of financing, the Company’s ability to repay borrowings with Comerica Bank and BroadOak, the Company’s dependence on sales and reimbursements from its clinical services, the Company’s ability to retain or secure reimbursement including its reliance on third parties to process and transmit claims to payers and the adverse impact of any delay, data loss, or other disruption in processing or transmitting such claims, and the Company’s revenue recognition being based in part on estimates for future collections which estimates may prove to be incorrect. Additionally, all forward-looking statements are subject to the “Risk Factors” detailed from time to time in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as amended, Current Reports on Form 8-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Because of these and other risks, uncertainties, and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, the Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

Contacts:

Investor Relations
Interpace Biosciences, Inc.
(855)-776-6419
Info@Interpace.com

FAQ

What were the key findings of Interpace Biosciences' latest clinical utility data for the ThyGeNEXT® + ThyraMIR®v2 test?

The data indicated improved accuracy in malignancy risk assessment, a decreased false-positive rate, and a 70% benign call rate.

Where was the data for the ThyGeNEXT® + ThyraMIR®v2 test platform presented?

The findings were presented at the American Thyroid Association (ATA) 2022 Annual Meeting.

What is the significance of the 70% benign call rate reported by Interpace Biosciences?

A 70% benign call rate suggests that a significant number of patients might avoid unnecessary surgeries, improving patient outcomes.

What challenges does Interpace Biosciences face regarding reimbursement of its tests?

Reimbursement is dependent on third-party providers, which may lead to financial risks and operational disruptions.