Startup's Cancer Test for the Healthy May Harm Public, FDA Says

Updated on
  • Pathway uses blood sample to detect early cancer signs
  • FDA calls test unproven and seeks meeting with company

The Food and Drug Administration said Thursday that a health-care startup’s cancer detection kit sold to healthy individuals is high-risk, could harm public health, and hasn’t been validated by science.

The FDA wrote to Pathway Genomics Corp. on Sept. 21 about the test, which retails for as much as $699. Patients get the test ordered by their doctor or one working for Pathway, then the company analyzes a blood sample for circulating traces of cancer. The company, which is backed by IBM Corp. and the venture capital firm Founders Fund, has touted the test as a less-expensive, faster way of detecting tumors.

The FDA said that Pathway’s testing kit counts as a medical device, and that the San Diego-based company hasn’t applied for regulatory clearance. There are other tests on the market that monitor patients who have been diagnosed with cancer already, though Pathway is the first to offer a test for healthy people. The FDA letter was posted online Thursday.

“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,” the FDA wrote to Pathway.

Liquid Biopsies

Doctors have been enthusiastic about the potential of so-called liquid biopsies as a low-cost, non-invasive alternative to traditional tissue samples. Yet more evidence is needed to validate their accuracy before they’re offered to consumers, physicians interviewed by Bloomberg have said.

The FDA said it appears CancerIntercept is a direct-to-consumer test, which Pathway said it disagrees with.

“We assure that there is physician involvement in the ordering, review and follow-up of CancerIntercept testing,” Pathway said in an e-mailed statement.

The company also said its product is a so-called laboratory-developed test that doesn’t require FDA clearance. Instead, Pathway said it’s governed by a U.S. Centers for Medicare and Medicaid Services program that ensures labs can perform accurate tests on patients. The FDA has said it intends to regulate some lab-developed tests to ensure the devices are accurate, and in the letter said it wants to meet with Pathway about what it did to validate the test’s accuracy.

“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,” Pathway said.

This isn’t the first time Pathway Genomics has heard from the FDA. The agency sent Chief Executive Officer Jim Plante a letter in 2010 about the lack of FDA clearance for its Genetic Health Report, a saliva collection kit that purported to tell consumers their risk for certain diseases and likelihood of responding to certain medications.

Pathway didn’t respond to a request for comment on FDA’s 2010 concerns.

Startup Trouble

Health-care startups have run into problems with regulators overseeing the very industry the companies are trying to disrupt. In 2013, the FDA told the genetic-testing company 23andMe Inc. to stop selling services that were meant to detect health conditions and disease risks. The FDA said 23andMe didn’t have agency clearance.

23andMe eventually gained FDA clearance for its platform to test people who want to determine if they carry certain serious diseases that could be passed on to their children, and is planning to bring back its health analysis by the end of the year.

(Updates with company comment starting in sixth paragraph.)
    Before it's here, it's on the Bloomberg Terminal. LEARN MORE