WASHINGTON — Makers of medical tests that have long escaped government scrutiny will have about four years to demonstrate that their new offerings produce accurate results, under a government rule that the testing industry strongly opposes.
The regulation finalized Monday by the Food and Drug Administration will phase in oversight of new tests developed by labs, a multibillion-dollar industry that regulators say poses increasing risks to Americans. The goal is to ensure that new tests for cancer, heart disease, COVID-19, genetic disorders and many other diseases are safe, accurate and reliable.
“The final rule announced today aims to provide critical oversight of these tests to ensure that important healthcare decisions are made based on test results that patients and healthcare providers can trust,” FDA Commissioner Robert Califf said in a press release.
Califf said inaccurate testing can lead to unnecessary treatment or delays in getting proper care.
But in a significant step, the FDA has decided that the tens of thousands of tests currently on the market do not need to undergo federal review. The agency said it will approve these tests essentially to address concerns that the new rule “could lead to the widespread loss of access to useful” tests.
Under the administration’s plan, newly developed tests that pose high risks — such as those for life-threatening diseases — must be approved by the FDA within three and a half years. Lower risk tests have four years to gain approval.
The FDA already reviews tests and kits made by medical device manufacturers.
But labs, major hospitals and universities that develop their own in-house tests have managed to bring them to market without all having been reviewed by an agency. The industry has resisted additional controls for decades, saying it will stifle innovation and drive up costs.
There are currently an estimated 80,000 medical tests available in about 1,200 laboratories, according to the agency’s estimate. They include tests for complex diseases, as well as for simpler conditions such as high cholesterol and sexually transmitted diseases.
According to the FDA, most laboratory tests in the 1970s and 1980s were “lower risk, low volume” products used primarily for local patients.
Over time, the tests have grown into a nationwide business, with labs processing thousands of blood, urine and other samples from hospitals and clinics every week. Others advertise directly to consumers, including some that claim to measure the risk of developing conditions such as Alzheimer’s disease and autism.
FDA officials have long raised concerns about the accuracy of some tests, pointing to patients who have received inaccurate results for heart disease, Lyme disease and other conditions. Inaccurate testing can lead to patients being misdiagnosed, skipping treatments, or undergoing unnecessary medications or surgeries.
More than a decade ago, the agency established stricter guidelines for the industry, but they were never finalized. For years, U.S. labs have successfully lobbied Congress and other federal agencies against stricter regulations.
When the FDA published a draft of the new rule last September, a leading industry group argued that the agency had no legal authority to enter the testing market.
The American Clinical Laboratory Association said Monday that it has “serious concerns about this rule, both from a policy and legal perspective. The rule will limit access to dozens of critical tests, increase healthcare costs and undermine innovation in new diagnostics.”
The group represents large testing chains such as Quest Diagnostics and LabCorp, but also smaller labs and test makers.
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