FDA Warns Liquid Biopsy Maker

According to the FDA, the company’s product, CancerIntercept Detect, has not undergone regulatory clearance as a “device” and could harm public health.

The FDA claims that Pathway’s CancerIntercept Detect, which costs $699, counts as a direct-to-consumer test because it ships blood collection tubes, technically considered to be medical devices, straight to customers. The test, a “liquid biopsy” that looks for genetic markers of cancer in raw blood samples, is sold as a non-invasive way to look for early signs of cancer in healthy individuals who have a family history of the disease.

“Based on our review of your promotional materials and the research publication cited above, we believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health”, said FDA Deputy Director James L. Woods in a letter to the company.

The FDA’s doesn’t now regulate so-called laboratory-developed kits, though it has a released a plan to do so in the future. But when we asked the company’s chief medical officer, Glenn Braunstein, how the diagnostic had been validated, it became clear that none of the evaluations performed by the company would actually be able to prove that the blood test works.

“While Pathway Genomics is involved in educating and marketing the tests to physicians and consumers, we do not believe this is a direct-to-consumer model”, the company wrote. Instead, Pathway said it’s governed by a U.S. Centers for Medicare and Medicaid Services program that ensures labs can perform accurate tests on patients. The letter goes on to state that the FDA would like to discuss with the company their validation strategy as well as evaluate data on clinical sensitivity and specificity of the test.

“We assure that there is physician involvement in the ordering, review and follow-up of CancerIntercept testing”, Arianpour said, noting the company believes the tool is a “laboratory developed test [LDT] and, as a CLIA [Clinical Laboratory Improvement Amendments] and CAP [Certified Authorization Professional] certified clinical laboratory, we are offering it as such”.

This isn’t the first time Pathway Genomics has heard from the FDA.

The FDA is concerned that people may seek treatment for tumors that do not require medical attention, or spend money and possibly seek out treatment they do not need at all – in either case, unnecessary treatment for cancer is potentially harmful to people, the agency said.