The FDA is moving to regulate some tests it says may be unreliable

The agency cannot stand by while Americans continue to rely on the results of these tests without making sure they work, FDA Commissioner Robert M. Califf said in a news release.

The new rules finalized Monday focus on the multibillion-dollar industry of laboratory-developed tests, known as LDTs, which are designed, manufactured and analyzed in a single laboratory as a screening and diagnostic tool. Major industry players, including academic medical centers that develop their own tests and large commercial labs, opposed the plan to further regulate medical tests when it came. proposed in September. Some analysts have said they expect opponents to sue the FDA to prevent the new rules from taking effect.

The rule will limit access to critical test scores, drive up health care costs and undermine innovation in new diagnostics, said Susan Van Meter, president of the American Clinical Laboratory Association, a trade group whose members include clinical laboratory giants LabCorp and Quest Diagnostics. a statement The group has argued that these tests are not medical devices, like pacemakers or stents, and should not be regulated in a similar way.

The FDA does not review most lab tests before patients use them. But he finalized a plan to phase in regulation of lab tests over four years. Lots of tests now they must go through FDA premarket review and meet other requirements, such as adverse event reporting.

The agency is allowing tests already in use to remain on the market without necessarily going through the new FDA rules, a move the agency says is aimed at addressing the risk that the cost of complying with the new requirements could lead to the loss of tests that patients rely on. .

Tests developed in the laboratory can be used to measure or detect a wide range of substances or markers in the body, including protein, glucose, cholesterol and DNA, all of which provide critical information about patients’ health.

Inaccurate results can have a significant and detrimental impact on the decisions patients make. For example, in 2022, the agency warned of the risk of false positives from a prenatal screening test that is commonly used to provide information about the possibility that a fetus may have a genetic abnormality, such as Down syndrome ; the FDA said it was aware of reports of women who ended their pregnancies based solely on the test.

Decades ago, LDTs ​​were much less common. But the prevalence of these tests has grown substantially with the ability to send blood and saliva samples from patients to laboratories across the country, the FDA said.

The Centers for Medicare and Medicaid Services are responsible for overseeing laboratories and their procedures. But it doesn’t assess how accurately a test identifies a disease or predisposition to a condition, which the FDA now aims to do.

The issue has been in the crosshairs of lawmakers on Capitol Hill for several years. Congress has failed to pass bipartisan legislation solidifying the agencies’ power. The lack of guidance led the agency to issue its own rules.

Some lawmakers have been critical of the rule as proposed, arguing that it extends beyond legislation Congress has considered.

Since the FDA is already struggling to keep up with innovation in what it currently regulates, this venture would mean fewer diagnoses, higher costs, and delays in care for patients who can’t afford to wait for the FDA approves a test that they need to finally calculate. Find out what’s going on, said Rep. Cathy McMorris Rodgers (R-Wash.), chairwoman of the House Energy and Commerce Committee, at a hearing in March.

But others have offered their support for allowing the FDA to go ahead on its own to regulate LDTs. In the same hearing, deputy Frank Pallone Jr. (N.J.), the top Democrat on the panels, said the use of lab-developed tests has grown substantially in recent years. That’s why the FDA’s proposal was an important step in eliminating patient harm from unnecessary treatment or undertreatment from inaccurate LDTs, he said.

This is a developing story. It will be updated.