FDA Warns Startup Selling Suspicious Blood-Based Cancer Tests
The Food and Drug Administration (FDA) sent a warning letter to Pathway Genomics last week about the blood-based cancer test the startup is selling.
The agency requested a meeting with Pathway’s CEO Jim Plante to discuss the data the company claims supports the test’s efficacy, as well as Pathway’s marketing materials.
Pathway Genomics is selling a diagnostic called the CancerIntercept Detect tool, which is a “non-invasive blood test that can be used by physicians as an early screening tool for the potential early detection of specific cancer types in patients who have not been diagnosed but are at an increased risk,” according to the company’s website.
CancerIntercept Detect can also identify 10 different types of cancer by scanning patient’s blood for small DNA fragments released by tumor cells called circulating tumor DNA (ctDNA), writes Popular Science.
However, the FDA wants to gain more insight into how the company decided this was the best method for early detection.
In the letter, the FDA said, “It is unclear how the literature that you cited, addressing the presence of circulating tumor DNA (ctDNA) in already-diagnosed patients, is adequate to support the expansive claims of screening for early cancer detection using ctDNA in undiagnosed patients for up to 10 different cancers with the CancerIntercept Detect.”
Also, the FDA is questioning Pathway’s marketing materials because the agency has no record of approving the device, which is a necessary step organizations must take before they can sell such products to consumers.
The team at Pathway is selling CancerIntercept Detect on a subscription pricing basis, between $299 and $699.
Ultimately, the FDA believes this test could pose a danger to patient safety, due to its lack of adequate scientific data.
Jim Plante seemed to echo that sentiment when he responded to the FDA memo, but added that he believed his team “performed appropriate validation” of CancerIntercept Detect as a lab-developed test and is currently in the middle of performing additional studies.
