Viome Life Sciences has launched CancerDetect Pancreatic, a physician-ordered blood test designed to detect pancreatic ductal adenocarcinoma by measuring enzyme activity associated with the disease.
In the company’s blinded validation, the test detected stage I and II pancreatic cancers with 86% sensitivity and 90% specificity against healthy controls. Unlike tests that rely on detecting tumor DNA, the technology measures enzymes involved in the breakdown of surrounding tissue, using signal amplification to detect very low concentrations.
The test is intended for adults aged 50 and older, with particular interest in people at elevated risk, including those with certain genetic mutations, a family history of pancreatic disease or recently diagnosed type 2 diabetes. Fountain Life is expected to be the first provider to offer the test to its members.
Important limitation: These results come from comparisons of serum samples from patients with pancreatic cancer and healthy adults. The test has not been evaluated in patients with pancreatitis or pancreatic cysts, and its performance in the intended-use population may differ. It is a laboratory-developed test performed in a CLIA-certified laboratory and has not been FDA-cleared or approved. It does not diagnose cancer or replace imaging, biopsy or clinical judgment.