Lab experts lash out at FDA move to beef up regulation of lab-developed tests

Dr. Curtis Hanson

As the FDA toughens its stance on lab-developed tests, some experts are pushing back at the agency's move, defending the tests' accuracy and saying that more regulatory action could unfairly restrict innovation.

More intense regulatory scrutiny would lead to "a serious and negative impact on our ability to provide high quality and accessible patient care," Dr. Curtis Hanson, CMO of Mayo Medical Laboratories, told The Wall Street Journal. Mayo Medical, which derives half of its $600 million revenue from lab-developed tests, says that cancer genetic tests would be delayed if FDA approval is required. Mayo Clinic doctors cited a 2013 study in the New England Journal of Medicine showing that cancer tests can help identify individuals who are good candidates for new, life-extending therapies.

If the FDA required that the tests undergo a review, it "might be harmful for some patients" because the product wouldn't be available to patients during that process, Axel Grothey, a Mayo Clinic oncologist, told the WSJ.

Even some experts who support tougher oversight of the tests have their doubts about the agency's plans to beef up regulation. Blood tests for genes that pinpoint breast cancer have varied results, sometimes leading to women getting unnecessary surgeries such as a mastectomy, Dr. Otis Brawley, medical director of the American Cancer Society, told the newspaper. Still, increasing regulation could "swing the pendulum too far in the other direction," Brawley said, leaving patients with fewer options.

Still, other medical professionals are pointing to the tests' questionable results as reason enough to ramp up regulation. "I see some of the claims made, and they're well ahead of the tests," said Dr. J. Leonard Lichtenfeld, deputy chief medical director of the American Cancer Society, as quoted by the WSJ.

Lab giant Quest Diagnostics ($DGX), for example, markets a screening test for a gene called KIF6 to flag a patient's predisposition to heart attacks and to see whether they're a good fit for statin therapy. By 2010, more than 160,000 people had the test, but the same year an analysis published in the Journal of the American College of Cardiology saw "no compelling evidence of an association" between KIF6 and higher risk of heart disease, the WSJ reports.

The findings offered a "valuable reminder of the potential pitfalls present in prematurely adopting a genomic test without sufficient evidence," Eric Topol and Samir Damani, cardiologists at La Jolla, CA-based Scripps Health, wrote at the time, as quoted by the WSJ.

- read the WSJ story (sub. req.)