The Food and Drug Administration on Thursday laid out a proposed new regulatory plan to oversee potentially thousands of laboratory-developed medical tests that the agency contends can be prone to errors.
These diagnostic and other tests are for diseases including cancer, heart disease and bacterial infections. They can also assess how well a given drug will help patients with a certain genetic makeup. For years, the FDA allowed these medical tests to be used as niche products at hospitals and labs largely without agency approval or scrutiny.
But these tests have proliferated nationwide over the past decade, and the FDA has decided to step in.
The agency says that is partly due to faulty lab-developed tests that have led to erroneous treatment for heart disease, to unneeded antibiotic use and to cancer patients' getting the wrong therapy. In one instance, a test for whooping cough eight years ago led to the incorrect belief that an epidemic was under way at a major New Hampshire hospital.
In a phone call with reporters, FDA Commissioner Margaret A. Hamburg said such tests have also led to incorrect diagnoses of autism. The agency will begin by scrutinizing "high-risk" tests, she said. There will be a lengthy time period first, including a 60-day notice to Congress and a comment period before the plan can become final.
Four Democratic senators wrote last month to the White House Office of Management and Budget, complaining that this guidance "has been languishing for years." They noted that the Centers for Disease Control and Prevention recently found "serious concerns" about misdiagnosis with a lab-developed test to detect Lyme disease.