The FDA thinks Pathway Genomics' cancer blood test could be harmful

By Arielle Duhaime-Ross on September 24, 2015 06:08 pm | See Original Here

'We believe you are offering a high risk test'

Pathway Genomics, the startup that's selling a suspicious cancer blood test, appears to have gotten what it deserves. The US Food and Drug Administration sent a letter to the company's CEO Jim Plante earlier this week citing a number of potential violations — most of which were pointed out in The Verge's own investigation of the product.

"We have [...] examined published literature and have not found any published evidence that this test or any similar test has been clinically validated as a screening tool for early detection of cancer in high risk individuals," the letter states. "We believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health."

The test "may harm the public health."

The blood test — called CancerIntercept — that Pathway Genomics is selling for $699 for was designed to detect cancer cell DNA. The company claims it could be an early warning for people who are at high risk of developing cancer, but who don’t yet have symptoms. Company CEO Plante told The Verge earlier this month that "the sensitivity of the test is very high and it can be used to potentially catch cancers at a much earlier stage." 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. Pathway Genomics hasn't completed a long-term study that shows that a positive test result leads to a cancer diagnosis.

In short, Pathway Genomics doesn't know if their product works. And anyone who gets a positive result using their CancerIntercept test could end up initiating a costly and unnecessary cancer treatment process. The FDA now wants to meet with Pathway Genomics to discuss how they validated the test.

Pathway Genomics issued a response to the FDA's letter in which the company states that they believe they "have performed appropriate validation of the test as a laboratory developed test, and we are in the process of performing additional studies." They also state that the company "greatly respects and shares the FDA’s concerns about patient safety" — just for good measure.