FDA Doesn’t Approve Pathway Genomics’ Cancer Blood Test
Pathway Genomics has developed the CancerIntercept™ Detect liquid biopsy that reportedly detects cancer in the bloodstream, and its product is marketed directly to consumers.
The blood test is a non-invasive way to to screen for the presence of specific genomic markers found in circulating tumor DNA (ctDNA) for up to ten different types of cancer in high risk populations.
If the company’s product works, it would offer many people a relatively inexpensive way to periodically test for cancer allowing for early detection and response.
The company offers the sale of the product and will bill the person’s insurance. Pathway Genomics acknowledges that the insurance company will likely deny the claim, but the company will fight to have the insurance company cover the cost.
If the claim is denied, the person will be responsible for the cost. Purchase is also available outright.
Though preliminary studies have been done and the technology looks promising, the Food FDA has looked into the product and hadn’t found enough evidence to support the company’s claim.
The FDA sent a letter to Jim Plante, Founder and CEO of Pathway Genomics, this week citing a number issues with the product and its marketing model.
The kit contains a medical device and the FDA indicated it has been:
“…unable to identify any Food and Drug Administration (FDA) records reflecting the approval, clearance, or listing of these devices.”
The FDA goes on to state:
“We have also 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… we believe you are offering a high risk test that has not received adequate clinical validation and may harm the public health.
It appears Pathway Genomics had jumped the gun with its release of its cancer detection product, and may have not have followed procedure in marketing directly to consumers, though the technology does look promising.
Tags: anti-cancer, cancer awareness
