FDA Will Begin to Regulate Thousands of Lab Tests

FRIDAY, Sept. 29, 2023 (HealthDay News) -- Faced with growing reports of inaccurate clinical lab tests, the U.S. Food and Drug Administration on Friday announced that it will for the first time regulate these vital diagnostic tools.

Many Americans might have assumed that the FDA already had oversight of all medical tests; it does not.

"According to the Centers for Disease Control and Prevention, 70% of today's medical decisions depend on laboratory test results," he noted. "Given the role these tests play in modern medical care, their accuracy and validity have a significant impact on public health."

But thousands of so-called "laboratory developed tests" (LDTs), analyzed at many high-tech labs, face no FDA oversight. These tests are often highly sophisticated and are used to identify cancers, sexually transmitted infections, and a host of other conditions.

Beyond that, some companies are now pitching their tests directly to consumers, the FDA noted. At the same time, reports of problematic tests have increased.

"The agency has become increasingly concerned that some LDTs may not provide accurate test results or perform as well as FDA-authorized tests," the agency said.

Inaccurate test results can lead to devastating consequences for patients.

"The FDA is concerned patients could initiate unnecessary treatment, or delay or forgo proper treatment altogether, based on inaccurate test results, which could result in harm, including worsening illness or death," the agency warned.

Pregnancy tests purporting to spot anomalies like Down syndrome, gene defects and cystic fibrosis have also come under scrutiny.

According to the Associated Press, the new rules are very long in the making: The FDA first proposed these changes over a decade ago.

The FDA says the new oversight will be phased in gradually over the next few years, to avoid "undue disruption to the testing market."

The agency claims that the new regulations will be a net cost benefit, due to "a reduction in health care costs associated with unsafe or ineffective tests, including tests promoted with false or misleading claims and from therapeutic decisions based on the results of those tests."

According to the AP, industry representatives have lobbied against FDA regulation of LDTs, claiming it would stifle innovation in the field.

The FDA is taking comments on the new proposals over the next 60 days.

SOURCES: U.S. Food and Drug Administration, news release, Sept. 29, 2023; Associated Press