Interpace Diagnostics Announces New Data Analyzing Imbalance of Short Tandem Repeat Alleles for Pancreatic Cancer Detection Published as an ASCO 2024 Abstract

PARSIPPANY, NJ, June 04, 2024 (GLOBE NEWSWIRE) — Interpace Diagnostics^®, a subsidiary of Interpace Biosciences^® (OTCQX: IDXG), is proud to announce 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 (asco.org/abstracts) 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 hypermutation 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.

“Understanding the capabilities and limitations of different sequencing platforms is crucial for advancing pancreatic cancer diagnostics,” said Nicole Massoll, MD, Chief Medical Officer at Interpace Diagnostics. “Our findings reveal that despite the promise of NGS and TGS for high-throughput analysis, challenges persist in accurately analyzing STRs, particularly in certain regions of interest.”

Syd Finkelstein, MD, Chief Scientific Officer at Interpace Diagnostics, continued, “Our data demonstrate that CE remains the gold standard for analyzing allelic imbalance, with data comparable to long-read TGS. Our data also showed that short-read NGS may not always provide accurate analysis, depending on the region of interest.”

“Our findings highlight the importance of sequencing platform selection for accurate STR analysis in pancreatic cancer detection,” said Jonathan Levine, Ph.D., M.B.A., Senior Director of Assay & Clinical Development at Interpace Diagnostics and an author of the abstract. He continued, “Our research underscores the broader implications of STRs in cancer biology, highlighting their role as epigenetic regulators and opening new avenues for understanding the molecular mechanisms underlying cancer development and progression, not only in pancreatic cancer but also in other cancer types.”

Tom Burnell, Ph.D., President, CEO, and Chairman of the Board of Interpace Biosciences provided additional comment, “This data firmly supports Interpace Diagnostics’ pioneering work with the PathFinderTG^® platform and PancraGEN^®. Our commitment to provide innovative diagnostic solutions and offer personalized insights for improved patient care remains strong.”

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 Company’s ability to continue to perform, bill and receive reimbursement for our PancraGEN^® molecular test under the existing local coverage determination (“LCD”), given that such LCD is currently under review by Novitas Solutions, Inc., the Company’s Medicare administrative contractor, 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 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, the Company’s revenue recognition being based in part on estimates for future collections which estimates may prove to be incorrect, and the possible removal of the Company’s common stock from trading on the OTCQX^®.

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, 2023, 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