As the new Congress and a new administration start up, the fate of FDA-issued regulations on laboratory-developed tests (LDTs) is one of many issues that health advocates and lobbyists will be ...

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, ...

Sept 18 (Reuters) - The U.S. Food and Drug Administration will rescind a rule that tightened regulations for clinical laboratories and gave the agency more oversight of diagnostic tests developed by ...

The recent landmark U.S. Supreme Court decision to overturn the Chevron doctrine could open the door to more challenges of Food and Drug Administration regulations, including the agency’s ...

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 ...

SAN LEANDRO, Calif., Sept. 02, 2022 (GLOBE NEWSWIRE) -- Nanomix Corporation (BTHE) (OTCQB: NNMX) (“Nanomix” or the “Company”), a leader in the development of mobile, affordable, point-of-care ...

A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests. The suit, filed in a Texas ...

The U.S. Food and Drug Administration (FDA or the Agency) issued a Final Rule on May 6, 2024 (89 FR 37286), that will, over the next four years, radically alter the landscape for laboratory-developed ...

The U.S. trade group representing laboratory companies and test manufacturers is suing to block the FDA from increasing its oversight of lab-developed tests, saying the agency overstepped its ...