A federal proposal to begin regulating some types of laboratory tests will be addressed during a public workshop Thursday and Friday.
Questions about the accuracy and marketing of some tests have raised increasing concern for regulators. Those led the Food and Drug Administration in November to propose a risk-based approach to regulating laboratory-developed diagnostic tests. The agency contends that regulating these tests will protect patients at a time when the genetic testing market is undergoing rapid growth.
Two of the nation's most powerful cancer groups—the American Cancer Society Action Group and the American Society of Clinical Oncology—support FDA regulation of these tests. The agency currently regulates diagnostic tests developed by manufacturers, which also have argued in favor of the FDA proposal.
“Every test presents a risk to patients,” said Andrew Fish, executive director of AdvaMed Diagnostics, a trade group representing diagnostic manufacturers. “That does not depend on who develops the test.”
But healthcare providers and the laboratories that develop the tests in question say the regulation will limit patient choices as well as potentially lead to the closure of many laboratories.
The proposal is “very duplicative of the regulation that we're already under,” Alan Mertz, president of the American Clinical Laboratory Association, told Modern Healthcare in August.
The American Hospital Association, the American Medical Association and the American Clinical Laboratory Association oppose the proposal. The tests are already regulated by the CMS as a result of a law passed in the late '80s, they say. Regulation will limit the new and clinically pioneering advances in genetic testing, they argue.
Such advances have occurred “in large part because of the nimbleness of relatively small clinical and academic laboratories that can quickly respond to new medical findings and patient needs by rapidly and safely developing and improving laboratory-developed tests,” the authors wrote in a Monday viewpoint piece published in JAMA.
A separate piece, also published Monday in JAMA, in support of the proposal argues that the FDA is right and regulation will mean laboratories will have to back up claims with research provided during the approval process rather than marketing a test with unverified claims. Manufacturers also will have an incentive to pursue approval, authors of this article.
The workshop begins at 8:30 am ET in Bethesda, Md. A webcast will be available online.
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