FDA extends oversight to lab tests to ensure accuracy

Makers of medical tests that have long escaped government oversight will have about four years to show that their new offerings deliver accurate results, under a government rule vigorously opposed by the testing industry.

The regulation finalized Monday by the Food and Drug Administration will gradually phase in oversight of new tests developed by laboratories, a multibillion-dollar industry that regulators say poses growing risks to Americans. The goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic conditions and many other illnesses are safe, accurate and reliable.

“The agency cannot stand by while Americans continue to rely on results from these tests without assurance that they work,” FDA Commissioner Robert Califf told reporters on a conference call.

Califf said inaccurate tests can lead to unnecessary treatment or delays in getting proper care.

But in a significant move, the FDA decided that the tens of thousands of tests currently on the market will not have to undergo federal review. The agency said it will essentially grandfather those tests into approval to address concerns that the new rule “could lead to the widespread loss of access to beneficial” tests.

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 3½ years. Lower risks tests will have four years to obtain approval.

All lab tests — old and new — will be required to register with the agency and report problems or errors. Based on this information, FDA officials said they will be able to target problematic tests.

The agency also won’t require approval of tests for which there are no alternatives, such as those for certain rare diseases.

There are an estimated 80,000 medical tests currently available from about 1,200 labs, according to the agency’s estimate. They include tests for complex diseases, as well as simpler conditions like high cholesterol and sexually transmitted infections.

In the 1970s and ’80s, most labbased tests were “lower risk, small volume” products used mostly for local patients, according to the FDA.

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 conditions like Alzheimer’s and autism. FDA officials have long voiced concerns about the accuracy of some tests.

DREAMSTIME/TNS The U.S. Food and Drug Administration on Monday put the final touches on a new regulation that seeks to ensure the accuracy of a broad spectrum of laboratory tests by extending the agency’s oversight, a move strongly opposed by the nation’s multibillion-dollar testing industry.