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Back and Forth on Lab-Developed Tests

As the US Food and Drug Administration beefs up its oversight of lab-developed tests, some test developers are pushing back, the Wall Street Journal reports.

FDA has argued that it needs to evaluate the safety and efficacy of such LDTs, as GenomeWeb has reported. In a recent report, the agency pointed out that false-positive results and insufficiently validated screening tests may have led to unnecessary medical procedures.

LDT defenders say, though, that their tests can save lives, the Journal says. The Mayo Clinic, for instance, offers a RAS mutation test that it says can guide treatment decisions for patients with metastatic colorectal cancer, noting that a 2013 study in the New England Journal of Medicine reported that such an approach could help extend patients' lives 29 percent longer than the standard therapy, the WSJ says.

Critics of increased regulation like Harvard University's Laurence Tribe and Georgetown University Law Center's Paul Clement questioned in report earlier this year sponsored by American Clinical Laboratory Association whether FDA even has the statutory authority to oversee LDTs. FDA's Alberto Gutierrez counters that federal law has long defined laboratory tests as medical devices, which the FDA can regulate.  

Further, LDT makers also argue that if their tests are taken off the market to be tested, patients will be left in the lurch. Curtis Hanson, the chief medical officer of Mayo Medical Laboratories, tells the Journal that closer regulation by the FDA would lead to "a serious and negative impact on our ability to provide high-quality and accessible patient care."

At the same time, proponents of tighter regulation say they worry about the consequences of selling tests with unproven effectiveness to the public. "I see some of the claims made, and they're well ahead of the tests," says Leonard Lichtenfeld, deputy chief medical director of the American Cancer Society.