- Pathway Genomics, a startup, has developed a blood test that it touts as a faster, less-expensive way to detect cancer.
- CancerIntercept is a direct-to-consumer test, which the FDA treats as a medical device.
- According to the FDA, the agency's analysis of the medical literature does not support use of this test as a clinically validated screening tool. The FDA informed Pathway in a warning letter that the test could "harm the public health" and has not been adequately validated by scientific evidence, Bloomberg reports.
Although the FDA considers CancerIntercept a medical device, Pathway Genomics has not applied for regulatory approval, which is one reason that the company received a letter from the FDA on September 21. One major regulatory issue is the fact that Pathway, which sells the test for $699, could be seen as using false claims to promote its product.
From the company's perspective, Pathway, which is backed by IBM and the venture capital company Founders Fund, is adamant that it assures physician involvement in ordering and reviewing CancerIntercept testing, as well as follow-up.
This situation is similar in many ways to what happened to 23andMe, a genetic-testing company, when the FDA told them to stop selling their services focused on detecting various health conditions and assessing disease risk. Eventually, 23andMe gained regulatory approval. Perhaps this is a good model for Pathway Genomics to follow.