Startups, Diagnostics

Pathway Genomics responds to FDA’s concerns on liquid biopsy test

Pathway Genomics has responded to FDA’s warning letter that its liquid biopsy test isn’t sufficiently validated clinically, and has an inappropriate marketing model.

San Diego liquid biopsy testmaker Pathway Genomics recently received a letter from the Food and Drug Administration warning against its CancerIntercept Detect diagnostic. The test, regulators say, may be misleading, is being in appropriately marketed directly to consumers and hasn’t received the appropriate clinical validation.

Pathway Genomics has rebutted FDA’s assertion, and will follow up with more.  It says it’s reviewing FDA’s concerns, but that physicians are overseeing the ordering, review and follow-up of the test.

“We believe that CancerIntercept Detect is a laboratory developed test and, as a CLIA and CAP certified clinical laboratory, we are offering at such,” Pathway Genomics wrote.

The FDA said, after all, in its warning letter that the Detect test didn’t have the appropriate regulatory approvals or clearances. Pathway Genomics made a splash in the news earlier this month with news that it had the first liquid biopsy cancer diagnostic to hit the market.

The test, Pathway Genomics says, can detect circulating tumor DNA in an individual’s bloodstream – and can determine if a person has one of several types of cancers. Pathway is directing this test at patients who are at high risk of developing cancer – say, a 65-year-old perpetual smoker who wants an early heads up if he has cancer.

The company has built a subscription model to make it easy for such users to take the test – $299 per test if they take it every three months. The test can only be administered with a physician’s OK. Pathway has an interesting telemedicine model for this – patients can remotely consult with Pathway-sanctioned doctors through video streaming, and then have their blood drawn at home by a Pathway-sanctioned phlebotomist.

Something about all of this has clearly tripped up the FDA – considering that literature hasn’t quite caught up with Pathways assertions that liquid biopsy testing is ready for the broader market. Here’s how Pathway responded:

“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. “We believe we have performed appropriate validation of the test as a laboratory developed test, and we are in the process of performing additional studies.”

[IMAGE: Flickr user Wheeler Cowperthwaite]