Interpace Diagnostics Group has expanded the use of its PancraGEN pancreatic cancer test for new indications, including biliary strictures and solid pancreatic lesions.
PancraGEN is claimed to be the first and only commercially available integrated molecular pathology test for pancreaticobiliary cancers.
Recently, the National Comprehensive Cancer Network (NCCN) Guidelines for Hepatobiliary Cancers recommend molecular testing in symptomatic patients with biliary obstruction or abnormality on imaging to diagnose the presence of cholangiocarcinoma.
The company has expanded the use of PancraGEN to solid pancreaticobiliary lesions based on guideline supported use of molecular testing and newly published clinical studies related to use of the test to diagnose both pancreatic and bile duct cancer (cholangiocarcinoma).
Interpace chief medical and scientific officer Syd Finkelstein said: “The recent NCCN Guidelines are an encouraging sign that molecular testing is now becoming the standard of care for diagnosis of both pancreatic and bile duct cancers and molecular results will be used more broadly to establish optimal treatment plans.”
Interpace president and CEO Jack Stover said: “We are pleased to see the updated NCCN Guidelines and the multiple peer reviewed papers that further support the use of molecular diagnostics in assessing the potential for pancreatic and bile duct cancers across a more expansive patient population.”
PancraGEN is a molecular and cancer risk classifier for cysts, solid lesions, and biliary strictures, which have potential for pancreatic or bile duct cancer.
The test will use a small sample of fluid or duct brush in cancer risk assessment. As per clinical studies, PancraGEN is 90% accurate, enabling effective risk stratification of patients with pancreatic cysts.
Interpace is an integrated commercial and bioinformatics company, which offers molecular diagnostic tests and pathology services to assess the risk of cancer.
At present, the company product portfolio includes four commercialized molecular tests and one test in a clinical evaluation process (CEP).
ThyGenX will be used for the diagnosis of thyroid cancer from thyroid nodules by using next generation sequencing assay, while ThyraMIR for the diagnosis of thyroid cancer from thyroid nodules by using gene expression assay.