FDA Says Cancer Detection Kit Is More Harmful than Helpful

The DIY movement is all the rage these days, but when it comes to one company’s cancer detection kit, you’re better off not doing it yourself.

As reported last month by Bloomberg News, the FDA deemed Pathway Genomics Corp.’s cancer detection kit marketed to healthy people to be high-risk. It said the kit could harm public health and has no scientific foundation.

The test, called CancerIntercept, sells for as much as $700. The test is ordered by a patient’s doctor or one working for Pathway. It analyzes a blood sample for traces of cancer. The company claims that the test is a less expensive, faster way of detecting tumors.

But the FDA said the testing kit falls under the definition of a medical device, and that the company didn’t apply for regulatory clearance to market it. Other tests are available to monitor patients who have been diagnosed with cancer, but Pathway is the first to promote one for healthy people.

In its letter to Pathway, the FDA said, “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 technology involved is known as “liquid biopsy,” and many practitioners are enthusiastic about its potential as a low-cost, noninvasive alternative to the traditional way of testing for cancer cells, in which tissue samples are removed from a suspicious mass. But the experts interviewed by Bloomberg said more evidence was needed to validate the accuracy of liquid biopsies before they’re marketed to consumers.

The FDA called CancerIntercept a direct-to-consumer test. Pathway said it wasn’t, that physicians had to be involved in ordering, reviewing and following up. That’s important from a regulatory perspective.

Pathway also claimed that CancerIntercept was a laboratory-developed test that doesn’t require FDA clearance, and is regulated by a U.S. Centers for Medicare and Medicaid Services program enabling labs to perform accurate tests on patients. The FDA intends to be involved with regulating some lab-developed tests to ensure accuracy, and wants Pathway to explain how it validated the test’s accuracy.

The FDA has looked askance at Pathway Genomics before. In 2010 it expressed concern over lack of clearance for Pathway’s Genetic Health Report. That kit involved collecting saliva that was analyzed and supposedly informed consumers about risk for certain diseases and how they were likely to respond to certain medications.

“Health-care startups have run into problems with regulators overseeing the very industry the companies are trying to disrupt.” Bloomberg reported. “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.”

Although 23andMe eventually achieved FDA approval for a test to determine if someone carries serious diseases that could be passed on to their children, it’s also planning to reintroduce its health analysis this year.

For more information about genetic tests, see Patrick’s newsletter, “Learning Your Own DNA Sequence: The Promise and Peril of Genetic Testing.”

Patrick Malone & Associates, P.C. listed in Best Lawyers Rated by Super Lawyers Patrick A. Malone
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