PathwayGenomics, a California company that sells direct-to-consumer blood tests for cancer is in hot water with the FDA.
The US Food and Drug Administration sent a stern letter to the manufacturer of a kit to test blood for signs of cancer. The agency said it is concerned the company, Pathway Genomics in San Diego, CA, is selling a cancer testing system directly to consumers and does not have the necessary FDA approvals or proof that the test works.
The company markets the device as "CancerIntercept Detect," and describes it as a "liquid biopsy."
In a Sept. 21 letter to company founder and CEO Jim Plante, the FDA's Jame Woods, deputy director of patient safety and product quality for the Office of In Vitro Diagnostics and Radiological Health wrote that the kit "appears to meet the definition of a device" and that the company is selling it directly to consumers. On the site instructions allow customers to fill out contact information so that an online physician can place their order.
The problem is that the FDA has no "published evidence that this test or any similar test has been clinically validated as a screening tool for early detection of cancer in in high risk individuals."
The company claims the test, which includes blood collection tubes, can detect up to 10 different types of cancer by looking for tumor DNA.
The FDA wants to meet with company representatives tbefore the end of October to discuss its claims and marketing practices.
"We believe you are offering a high risk test that has not recieved adequate clinical validation and may harm the public health," Woods wrote in the letter.
"We are carefully considering the concerns of the FDA as stated in their letter, and we will be responding to that letter," the company said. The statement
Responding to the FDA in a statement on its site, Pathway Genomics denied it is selling the device directly to consumers.also said that as a certified laboratory Pathway is allowed to devise tests and testing equipment.
The company, which has several prominent people on its board--including a former US Secretary of Commerce and a former chairman of the US Joint Chiefs of Staff, sells the testing system and monitoring service for $699--more if the buyer choses quarterly payments.