Washington: Creator of medical tests who have been on the run for a long time government inspection It will take about four years to show that their new offerings produce accurate results, under a government rule that the testing industry has vigorously opposed.

The regulation finalized Monday by the Food and Drug Administration would gradually phase in oversight of new tests developed by laboratories. billion dollar industry Regulators say this is increasing the risk to Americans. The goal is to ensure that new tests for cancer, heart diseaseCOVID-19, genetic conditions and many other diseases is safe, accurate and reliable.

“The agency cannot remain silent while Americans continue to rely on the results of these tests without assurances 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 appropriate care.

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

Under the government’s plan, most newly developed tests that pose a higher risk — such as those for life-threatening diseases — would need to be approved by the FDA within 3 1/2 years. Low-risk tests will have four years to gain 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 would be able to target problematic tests.

“If we identify problems in trials we can move forward to take action against them,” said Dr. Jeff Shuren, director of the FDA’s device center. “We think it strikes the right balance overall.”

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

The FDA already reviews tests and kits made by medical device manufacturers.

But laboratories, large hospitals and universities that develop their own in-house tests are able to market them without each agency’s review. The industry has opposed additional scrutiny for decades, saying it would stifle innovation and increase costs.

According to the agency’s estimates, there are currently an estimated 80,000 medical tests available in approximately 1,200 laboratories. These include tests for complex diseases as well as simple conditions like high cholesterol and sexually transmitted infections.

According to the FDA, in the 1970s and 80s, most laboratory-based tests were “low-risk, small-volume” products, used mostly for local patients.

Over time, testing has become a nationwide business, with laboratories processing thousands of blood, urine and other samples per week from hospitals and clinics. Others advertise directly to consumers – including those claiming to measure the risk of developing diseases such as Alzheimer’s and autism.

FDA officials have long expressed concerns about the accuracy of some tests, pointing to patients who have received false results for heart disease, Lyme disease and other conditions. Inaccurate tests can cause patients to be misdiagnosed, skip treatment, or not receive treatment at all. unnecessary medicine Or surgery.

More than a decade ago, the agency drafted strict guidelines for the industry, but they were never finalized. Over the years, US laboratories have successfully lobbied Congress and other federal institutions Against strict regulation.

When the FDA released a draft of the new rule last September, a major industry group argued that the agency did not have the legal authority to step into the testing market.

The American Clinical Laboratory Association said on Monday that it had “serious concerns about this rule, both as a matter of policy and law. This rule will limit access to many important tests, increasing the number of tests that can be performed.” health care costsAnd stifling innovation In the new diagnosis.”

The group represents large testing chains such as Quest Diagnostics and LabCorp, as well as smaller laboratories and test manufacturers.