“This ruling affirms what we and our colleagues across the industry have long maintained: the FDA lacks the legal authority to regulate LDTs,” said Martin Price, Executive Chairman & CEO of ...

Folks with cancer that has gene variants or rare diseases often need laboratory-developed tests for information that could guide their treatment when commercial tests don’t exist or aren’t precise ...

The Biden administration's contentious plan to increase federal regulation of diagnostic medical tests could be swiftly dialed back after President-elect Trump is sworn in. The big picture: ...

The FDA has scrapped a rule that would have allowed the agency to regulate lab-developed tests as medical devices. Under the rule, the FDA would have phased in oversight of laboratory-developed tests ...

Laboratories are just beginning to assess the magnitude of operational changes needed to comply with a new federal rule expanding regulatory oversight of lab developed tests (LDTs). In a major shift, ...

A federal district court has struck a blow for medical innovation and patient empowerment by overruling the Food and Drug Administration's (FDA) misbegotten effort to regulate laboratory-developed ...

A federal judge in Texas ruled that the FDA overstepped its authority when it issued its Final Rule: Medical Devices; Laboratory Developed Tests in May of last year, which said laboratory-developed ...

The FDA’s landmark final rule on Laboratory Developed Tests (LDTs) is set to transform the regulatory landscape for diagnostic laboratories. This webinar will provide biomedical diagnostics ...