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.