The US Food and Drug Administration sent an untitled letter this week to Pathway Genomics, citing the agency's concerns regarding the company's CancerIntercept Detect test, as GenomeWeb has reported.
In the letter, FDA says it appears that Pathway Genomics is offering its liquid biopsy screening test for cancer under a direct-to-consumer model, and the agency cannot locate any "records reflecting the approval, clearance, or listing of these devices."
The agency also expressed concerns regarding the clinical validation of the test. "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 FDA says.
"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," the agency adds. It then asked Pathway Genomics to set up a meeting with the agency.
The Verge notes that it recently spoke with Pathway Genomics' CMO, Glenn Braunstein, who said that the validation tests were performed on people with known, well-defined cancers, not people who weren't yet diagnosed with disease.
On its website, Pathway Genomics notes its receipt of the FDA letter, says it is considering the agency's concerns, and adds that it will be responding to the letter. The company also says that it believes that its CancerIntercept Detect is a laboratory-developed test and that it is offering it as a CLIA and CAP certified lab. It also says that physicians are involved in the ordering, review, and follow-up of testing.
"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," the company adds.