will have about four years to show that their new offerings deliver accurate results, under a government rule vigorously opposed by the testing industry.
Under the government's plan, most newly developed tests that pose a high risk — such as those for life-threatening diseases — will need to be FDA approved within 3 1/2 years. Lower risks tests will have four years to obtain approval. The agency also won’t require approval of tests for which there are no alternatives, such as those for certain rare diseases.But labs, large hospitals and universities that develop their own in-house tests have been able to market them without each one undergoing agency review. The industry has resisted additional scrutiny for decades, saying it will stifle innovation and drive up costs.
Over time, the tests have grown into a nationwide business, with labs processing thousands of blood, urine and other samples per week from hospitals and clinics. Others advertise directly to consumers — including some claiming to measure the risk of developing ailments like Alzheimer’s and autism. When FDA released a draft of the new rule last September, a leading industry group argued the agency did not have legal authority to step into the testing market.