Viome PRO launches pancreatic cancer blood test in US for early detection

USA—Viome Life Sciences has launched CancerDetect Pancreatic in the United States to help physicians identify pancreatic ductal adenocarcinoma (PDAC), the most common type of pancreatic cancer, at an earlier stage.

The physician-ordered blood test is part of the company’s clinical diagnostics portfolio and targets an area where early detection remains challenging.

Enzyme-based technology targets early-stage disease

CancerDetect Pancreatic uses an enzyme activity assay to identify biological signals associated with tumours.

Rather than detecting cancer through imaging or directly measuring tumour cells, the test assesses enzymes that break down surrounding tissue.

The technology uses a signal amplification process in which each target enzyme molecule cleaves multiple sensor molecules.

This approach enables the assay to detect enzymatic activity at attomole to femtomole concentrations, potentially allowing it to identify cancer-associated signals when they are present at low levels.

In blinded validation testing involving serum samples from patients with PDAC and healthy adults, the test achieved 90% specificity and detected 86% of stage I and II cancers.

These findings suggest potential for early-stage detection, but performance in broader clinical populations requires further assessment.

The test is performed in a laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA).

However, the US Food and Drug Administration (FDA) has not cleared or approved it, a distinction healthcare providers and prospective users must consider when evaluating the assay.

Clinical limitations and target population

Viome PRO states that CancerDetect Pancreatic is not intended to diagnose cancer independently.

A result indicating that cancer was not detected does not rule out the disease, while a positive result requires further clinical evaluation and pancreatic imaging.

The company also advises that the test does not replace biopsy, imaging or medical judgment.

The assay has not been evaluated in people with pancreatitis or pancreatic cysts, limiting the available evidence on its performance in these groups.

Viome PRO president Brad Younggren said his experience as a physician had exposed him to patients whose pancreatic cancer was discovered at an advanced stage despite previously identified risk factors.

He emphasised the importance of surveillance and early detection, noting that existing tests have limitations in identifying early-stage disease.

 According to Younggren, additional testing could support surveillance among high-risk patients.

The company designed the test for adults aged 50 and older, including smokers, heavy alcohol users, people with a family history of pancreatic disease, individuals with specific genetic mutations, and those recently diagnosed with type 2 diabetes.

Access through healthcare providers

Patients can access testing through routine venous blood collection or nationwide mobile phlebotomy services.

Viome developed and validated the assay after exclusively licensing the underlying technology from Oregon Health & Science University.

Preventive healthcare company Fountain Life will be the first provider to offer CancerDetect Pancreatic to its members.

Its centres operate in Houston, Dallas, Orlando, Naples and White Plains, New York, with additional locations planned in Los Angeles and Miami.

The launch expands Viome PRO’s clinical diagnostics offering, which also includes Gut Health PRO, Precision Health PRO, CancerDetect Oral & Throat and Oral Health PRO.

For the diagnostics industry, the launch introduces another blood-based method for detecting cancer, an area drawing interest as healthcare providers look for ways to identify disease before symptoms become pronounced.

Its clinical role will depend on further evidence of performance, appropriate patient selection and how physicians incorporate results into established diagnostic pathways.

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