According to a new report by SNS Insider, the Laboratory Developed Tests Market was valued at USD 12.43 billion in 2023 and is projected to reach USD 23.03 billion by 2032, at a CAGR of 7.11% during ...

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.

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 ...

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 ...

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 ...

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.

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 ...

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 ...

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 ...

US Food and Drug Administration (FDA) Commissioner Margaret Hamburg recently announced that her agency would soon end a long-standing policy of enforcement discretion toward a classification of ...

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 ...

This archived news story is available only for your personal, non-commercial use. Information in the story may be outdated or superseded by additional information. Reading or replaying the story in ...