WASHINGTON, Feb. 19, 2025 /PRNewswire/ -- Laboratory developed tests play an essential role in diagnosing and treating many of the conditions that affect pediatric patients. Join the Association for ...

Austin, United States, June 22, 2026 (GLOBE NEWSWIRE) -- The Laboratory Developed Tests Market was valued at USD 14.27 Billion in 2025 and is expected to reach USD 28.31 Billion by 2035, growing at a ...

Previously, this blog covered the FDA’s decision to regulate lab-developed tests (LDTs) as medical devices. However, a ruling from a federal district court in Texas earlier this year has changed that.

A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...

Add Yahoo as a preferred source to see more of our stories on Google. An employee in the ARUP Laboratories Molecular Infectious Diseases Lab prepares a specimen for COVID-19 testing. The Salt Lake ...

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 ...

On April 29, 2024, the Food and Drug Administration (FDA) announced a final rule to consider laboratory-developed tests (LDTs) to be medical devices and thus under FDA oversight. 1 LDTs are laboratory ...

After nearly a year’s worth of trepidation about how laboratory-developed tests (LDTs) could be regulated, there appears to be no path for FDA to assume its oversight. The vacating of the final rule ...

The US Food and Drug Administration (FDA) on Friday said it will wait for the new administration and halt the finalization of guidance that would have changed the way lab-developed tests (LDTs) are ...

Kadakia is a medical student at Harvard Medical School. Ross and Ramachandran are physicians and professors at the Yale School of Medicine. They submitted an amicus brief in support of the FDA in ACLA ...

For years, the US Food and Drug Administration (FDA) has provided leeway to a sub-category of diagnostic tests known as laboratory-developed tests, or simply LDTs. But according to FDA Commissioner ...

The 2024 election results will have vast consequences for health policy, but one of the less visible effects will be to once again disrupt how the federal government regulates diagnostic tests.