The US Food and Drug Administration, responding to growing concerns that a host of diagnostic tests for illnesses from cancer to Lyme disease may be inaccurately identifying conditions, announced Thursday that it intends to regulate many of the tests.
Thousands of tests on the market take advantage of a legal loophole that exempts them from requirements that their makers prove they correctly identify what they claim to, forcing doctors and patients to decide which tests are legitimate.
FDA commissioner Margaret Hamburg said during a news conference that her agency was aware of faulty tests, such as those that led cancer patients to receive inappropriate treatment and those for autism.
“Inaccurate test results could cause patients to seek unnecessary treatment or delay and sometimes forgo treatment altogether,’’ said Hamburg.
Oversight will be phased in over nine years, with the first batch of highest-risk tests subject to FDA review a year after the proposed rules are finalized. Some of these tests are developed in Cambridge and Greater Boston’s thriving biotech industry.
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