IDXG Interpace Biosciences Inc

Interpace Biosciences, Inc. (Nasdaq: IDXG) announced today 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 percent 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”, (Gastroenterology 2019; 157:720-730). 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 flagship 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.

Koushik K. Das, MD, an assistant professor of medicine in the Division of Gastroenterology at Washington University said: “We are thrilled to bring our discoveries from the bench to the bedside with the help of Interpace. Utilizing Das-1 to identify patients at risk of pancreatic cancer has been our goal for many years.” Details of the Agreement were not provided.

According to Tom Burnell, President & CEO of Interpace, “The Agreement with these highly respected institutions represents an important evolution of our GI franchise as we strive to provide the most comprehensive risk assessment tool available for physicians and their patients.” He continued, “This is also another indication of our commitment to innovation and expanding our clinical expertise even further.” 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 assessments, 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 a leader in enabling personalized medicine, offering specialized services along the therapeutic value chain from early diagnosis and prognostic planning to targeted therapeutic applications.

Interpace Diagnostics is a fully integrated commercial and bioinformatics business unit that 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 four commercialized molecular tests and one test in a clinical evaluation process (CEP): PancraGEN® for the diagnosis and prognosis of pancreatic cancer from pancreatic cysts; 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 vs. metastatic origin. In addition, BarreGEN® for Barrett’s Esophagus, is currently in a clinical evaluation program whereby we gather information from physicians using BarreGEN® to assist us in positioning the product for full launch, partnering and potentially supporting reimbursement with payers.

Interpace’s Biopharma provides pharmacogenomics testing, genotyping, biorepository and other customized services to the pharmaceutical and biotech industries. The Biopharma Business 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, and improving patient care.

For more visit Interpace Biosciences’ website information, please 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 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 its $5M secured bridge loan, the Company’s ability to maintain its Nasdaq listing in light of its failure to meet minimum stockholder equity requirements as of June 30, 2020, as well as the increased difficulty in meeting the minimum stockholders’ equity requirement as a result of the impairment charge, 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 most recent Annual Report on Form 10-K filed on April 22, 2020, 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 RelationsEdison GroupJoseph Green/ Megan Paul(646) 653-7030/7034jgreen@edisongroup.com/mpaul@edisongroup.com