FDA Turns Its Eye on Pathway's 'Direct-to-Consumer' Cancer Test

Sep 25, 2015, 15:15 PM by Michael Croft

Diagnostics World | This Thursday, the FDA sent a letter to Pathway Genomics warning the company that a newly introduced test, a liquid biopsy to find early-stage cancer in apparently healthy people, has not been clinically validated and could be harmful to public health. The letter not only calls attention to the shaky evidence for this test's accuracy, but also asserts the FDA's authority over a whole category of tests in a regulatory gray area.

By Aaron Krol

September 25, 2015 | This Thursday, the FDA publicly posted a letter to Pathway Genomics of San Diego, Calif., expressing strong concern about a test the company recently launched called CancerIntercept Detect. 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.

When the test was first released earlier this month, many observers were skeptical that this was a reasonable indication for genetic testing, or that Pathway had properly vetted the test before offering it for sale. Arielle Duhaime-Ross of The Verge, after speaking with both the CEO and Chief Medical Officer of Pathway, concluded that “the company itself doesn’t know if its claims are true,” noting that Pathway has not run any long-term studies to learn whether patients diagnosed with cancer by CancerIntercept Detect or other liquid biopsies actually go on to develop the disease.

Read the whole story, including a statement from the FDA on its jurisdiction over this test, at Diagnostics World.