Viome Life Sciences’ clinical division Viome PRO has launched CancerDetect Pancreatic, a physician-ordered blood test designed to identify pancreatic ductal adenocarcinoma.
The assay assesses the enzymatic activity tumours to break down surrounding tissue.
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This enables detection at attomole-to-femtomole concentrations because each target enzyme molecule cuts multiple sensor molecules to amplify the signal.
In blinded validation testing using serum from patients with pancreatic ductal adenocarcinoma and healthy adults, the test achieved 90% specificity while detecting 86% of stage I and II cancers.
Performed in a Clinical Laboratory Improvement Amendments (CLIA)-certified laboratory, the test has not been cleared or approved by the US Food and Drug Administration (FDA).
It does not diagnose cancer directly, and a not-detected result does not exclude the condition.
Positive results require clinical evaluation and pancreatic imaging, with the company noting that the tool does not replace biopsy, imaging, or medical judgment. The test has not been assessed in people with pancreatitis or pancreatic cysts.
Viome PRO president Brad Younggren said: “As a physician, I have witnessed advanced pancreatic cancer discovered in patients who had known risk factors.
“Surveillance with early-stage detection is incredibly important in pancreatic cancer, and it is where every existing test underperforms.
“Having a best-in-class diagnostic test for early disease detection will allow for much better early surveillance in higher-risk patients.”
The test is designed for adults aged 50 years and above, including higher-risk groups such as smokers, heavy alcohol users, individuals with a family history of pancreatic disease, people with specific genetic mutations, and those recently diagnosed with type 2 diabetes.
Blood samples are drawn as routine venous samples or collected nationwide through mobile phlebotomy. Viome developed and validated the test after exclusively licensing the underlying technology from Oregon Health & Science University.
Preventive healthcare company Fountain Life will be the first provider to offer the test to members.
The company operates centres in Houston, Dallas, Orlando, Naples, and White Plains, New York, with branches opening soon in Los Angeles and Miami.
The test joins Viome PRO’s clinical diagnostic portfolio, which comprises Gut Health PRO, CancerDetect Pancreatic, Precision Health PRO, CancerDetect Oral & Throat, and Oral Health PRO.
