NEWS: FDA to regulate diagnostic tests for Lyme disease
In a move that could have profound implications for the Lyme community, the FDA announces it will regulate Lyme diagnostic tests. (Why we’re concerned: Standard, government-approved testing misses most cases of Lyme disease. Specialized testing has helped many Lyme patients get properly diagnosed and treated.)
By Beth Daley and Samantha Costanzo, New England Center for Investigative Reporting
July 31, 2014
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.