PARSIPPANY, N.J.—Late 2018 saw Interpace Diagnostics Group Inc. announce that a new scientific paper was published, with the primary conclusion showing that DNA analysis using PancraGEN has a favorable impact on patient outcomes, particularly in patients with cysts that have worrisome features, supporting more accurate surgery and surveillance decisions.
The paper, entitled “The Incremental Value of DNA Analysis in Pancreatic Cysts Stratified by Clinical Risk Factors,” was published in the November edition of Gastrointestinal Endoscopy. The three DNA abnormalities examined in the study, all of which are included in the PancraGEN assay, included: elevated DNA quantity, KRAS mutation and loss of heterozygosity (LOH) mutations among a panel of key tumor suppressor genes.
The authors of the article included Dr. James Farrell of Yale University, Dr. Mohammad Al-Haddad of Indiana University and Dr. Tamas Gonda of Columbia University, and the study assessed a total of 478 patients. Of this cohort, 209 had surgical pathology-derived outcomes, and 269 had clinical follow up of two to eight years. Among patients with worrisome cysts, the presence of multiple DNA abnormalities significantly increased risk of malignancy, and the absence of all DNA abnormalities significantly decreased risk to very low levels. Importantly, the absence of all DNA abnormalities de-escalated risk in 50 percent of worrisome cysts.
Said Jack Stover, president and CEO of Interpace: “This newly published study representing nearly 500 patients, authored by these luminaries from such highly respected institutions in a top-tier peer-reviewed journal, provides the most important evidence to date that the use of PancraGEN can significantly improve outcomes in targeted patient populations.”
PancraGEN is a molecular, cancer risk classifier for cysts, solid lesions and biliary strictures that have potential for pancreatic or bile duct cancer. The company also now offers a “molecular only” version of PancraGEN called PanDNA that only reports the molecular results, enabling clients to conduct their own comprehensive clinical risk assessment based on DNA abnormalities tested by PancraGEN.