A Food and Drug Administration proposal to regulate laboratory-developed tests could upend a clinical sector that provides thousands of tests to healthcare providers every day, raising costs and potentially limiting patient access, detractors say.
Or it could save people from the harm caused by poorly regulated tests, supporters of the new regulations contend.
The two sides engaged in heated debate during a two-day workshop last week featuring dozens of speakers representing laboratories, healthcare providers and patients.
The medical-device industry supports the proposed regulation. But other groups, such as the American Hospital Association and the American Medical Association, say FDA regulation will raise costs and potentially hinder patient access.
Supporting the FDA, Laura Koontz, director of policy for the Ovarian Cancer National Alliance, noted the harm unregulated tests can do. For example, some women tested for ovarian cancer with a specific laboratory-developed blood test chose to have their ovaries removed as a result of inaccurate test results. “What we do know is that many women were given dangerous and inaccurate results—with real consequences,” Koontz said in her testimony.
The FDA regulates diagnostic tests developed by laboratory manufacturers. Last year, it developed a risk-based framework to regulate laboratory-developed tests.