|Pathway Genomics CEO Jim Plante|
The FDA is cracking down on Pathway Genomics for improperly marketing its liquid biopsy test, a couple of weeks after the company rolled out its product directly to consumers for the early detection of cancer.
Last week, San Diego-based Pathway said it would sell its CancerIntercept Detect product to consumers for $299, allowing high-risk individuals to check DNA in their blood for early warning signs of the disease. But under this business model the company is shipping blood collection tubes to patients, and no FDA records show "approval, clearance or listing of these devices," the agency said in its letter.
Plus, Pathway has not shown that its test is an effective screening method for cancer, the FDA added. The agency reviewed scientific literature and did not find "any published evidence" that CancerIntercept Detect or a similar test was clinically proven as a screening tool for early detection of cancer in high risk patients, it said in its letter. And a white paper on liquid biopsy published on the company's website did not provide any information about the test's efficacy.
"Based on our review of your promotional materials and the research publication cited above, we believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health," the FDA said in its note.
The agency is giving the company 15 business days to respond to its letter and lay out a timeline for meeting with regulators to discuss the product. "We … are committed to working with you as we strive to protect the public health without unnecessarily imposing regulatory burdens on the marketing of products of potential clinical importance," the FDA said in its letter.
The action deals a blow to Pathway, which has been working hard to bring its liquid biopsy test for market after resolving a patent feud over BRCA testing technology with archrival Myriad Genetics ($MYGN). In January, the company settled the score with Myriad, dismissing all outstanding litigation and opening the door for increased sales of its liquid biopsy product.
"We are very pleased to close this chapter and continue our focus on providing innovative cancer risk testing to patients around the world," Jim Plante, Pathway Genomics founder and CEO, said at the time.
A couple weeks ago, the company launched CancerIntercept Detect and another tool to monitor cancer treatment, disease progression and recurrence. The company already kicked off two clinical trials to evaluate its liquid biopsy test in patients but has not yet published results, Plante said at the time of the launch.
- read the FDA letter (PDF)