Interpace Biosciences Announces U.S. PTO Issuance of Patent No. 11,143,657 Titled: Topographic Genotyping for Determining the Diagnosis, Malignant Potential, and Biologic Behavior of Pancreatic Cysts and Related Conditions

Rhea-AI Summary

Interpace Biosciences announced the granting of US Patent 11,143,657 for its PancraGEN technology, aimed at improving the diagnosis and management of pancreatic cysts. This patent enhances the molecular diagnostic capabilities of PancraGEN^®, which has been used on over 40,000 cyst samples, boasting a 90% accuracy in risk assessment. The technology aims to better handle pancreatic cancer, a leading cause of cancer deaths in the U.S. This patent solidifies Interpace’s role in personalized medicine, targeting effective cancer diagnosis and treatment solutions.

Positive

• US Patent 11,143,657 granted for PancraGEN technology enhancing pancreatic cyst diagnosis.
• PancraGEN^® has demonstrated 90% accuracy in risk assessment.
• Over 40,000 pancreatic cyst samples have been analyzed using PancraGEN^®.

Negative

• Dependence on third-party reimbursement processes may impact financial performance.
• The company has a history of operating losses and substantial doubt about its ability to continue as a going concern.
• Potential adverse effects from COVID-19 on operations and revenues.

PARSIPPANY, NJ, Oct. 28, 2021 (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 that on October 12^th 2021, the United States Patent and Trademark Office granted it an US Patent (11,143,657) titled: Topographic genotyping for determining the diagnosis, malignant potential, and biologic behavior of pancreatic cysts and related conditions.

This patent covers the underlying technology used in PancraGEN^®, Interpace’s flagship product for risk stratification of Pancreatic cysts. PancraGEN^® is 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 to date.

According to Syd Finklestein, MD, an inventor of this patent and Chief Scientific Officer of Interpace Biosciences, “The PancraGen patent represents our commitment to deliver clinically actionable molecular testing that will help better manage pancreatic cancer, a leading cause of cancer deaths in the United States. The creative approach behind this patent represents both new ideas and a novel approach to build our understanding of the biology behind this aggressive cancer.”

About PancraGEN^®

PancraGEN^® is a pancreatic cyst molecular test that, by using a small sample of pancreatic cyst fluid, can aid in pancreatic cancer risk assessment. PancraGEN^® is 90% accurate, according to clinical studies, enabling effective risk stratification of patients. Pancreatic cancer is often difficult to diagnose in early stages and typically spreads rapidly with signs and symptoms appearing when the cancer is significantly advanced. Because of this, and that complete surgical removal of the pancreas is not possible, pancreatic cancer is considered a leading cause of cancer deaths.

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, provides clinically useful molecular diagnostic tests, 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^® for the diagnosis of thyroid cancer from thyroid nodules utilizing a proprietary gene expression assay; 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 clinical evaluation program (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.

Pharma services, through Interpace Pharma Solutions, provides pharmacogenomics testing, genotyping, biorepository and other customized services to the pharmaceutical and biotech industries. Pharma services also advances personalized medicine by partnering with pharmaceutical, academic, and technology leaders to effectively integrate pharmacogenomics into their drug development and clinical trial programs with the goals of delivering safer, more effective drugs to market more quickly, while also improving patient care.

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 adverse impact of the COVID-19 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, the Company’s ability to repay borrowings under its new credit facility as well as its $7.5M bridge loans from its private equity investors, 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 Company’s ability to remediate material weaknesses in internal controls. 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, 2020 filed with the Securities and Exchange Commission, Current Reports on Form 8-K and Quarterly Reports on Form 10-Q. 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 is the significance of US Patent 11,143,657 for Interpace Biosciences?

The patent enhances the PancraGEN technology, crucial for diagnosing pancreatic cysts, thereby improving patient care.

How accurate is PancraGEN in assessing pancreatic cyst risk?

PancraGEN^® claims 90% accuracy based on clinical studies.

How many samples have been processed using PancraGEN?

Over 40,000 pancreatic cyst samples have been processed using the technology.

What challenges does Interpace Biosciences face according to the press release?

Interpace faces a history of operating losses, dependence on third-party reimbursements, and potential COVID-19 impacts.