TEST:

PancraGEN®

"Interpace Diagnostics, a subsidiary of Interpace Biosciences...responded to the undefined extension granted by Centers for Medicare & Medicaid Services (CMS) to Novitas, its Medicare Administrative Contractor (MAC). Novitas announced late last week that CMS granted an extension to the final decision for Local Coverage Determination (LCD) of Genetic Testing for Oncology (L39365) in order for all comments received in response to the proposed changes to be thoroughly considered."

However this study shows the increase in sensitivity in detection of cysts with IPMN/MCN pathology by combining size CEA and DNA analysis. These findings can validate serial surveillance by EUS with FNA as DNA and CEA levels can morph over time and also provide improved guidance on potential premalignant mucinous cysts.

"On July 6, 2023, Novitas Solutions, Inc. announced that it was rescinding implementation of the Genetic Testing for Oncology LCD (L39365) so that it will not become effective on July 17, 2023. As a result, Interpace is able to continue offering PancraGEN..."

"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-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 cancer posed by pancreatic cysts and is used to rule-in and rule-out (risk-stratify) the disease."