The Food and Drug Administration aims next year to toughen up regulations on the lab-developed testing industry, according to an article in The Wall Street Journal. Here are three things to know about ...

The market for lab-developed tests, now worth $4.5 billion globally, is expected to see 7 percent compound annual growth through 2028, according to a new Research and Markets report. The report ...

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, ...

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 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 March 31, 2025, in the U.S. District Court for the Eastern District of Texas vacated the Food and Drug Administration’s (FDA) final rule, in which FDA attempted to assert regulatory authority over ...

Historically, developing a molecular test within a clinical laboratory has been perceived as a complicated and laborious process. In this webinar, we aim to dispel common misconceptions of laboratory ...

The Biden administration's contentious plan to increase federal regulation of diagnostic medical tests could be swiftly ...

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 ...

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.

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