MobiHealthNews

Texas judge strikes down FDA rule on lab-developed tests regulation

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 ...
Labroots

Optimizing Laboratory-Developed LC-MS/MS Tests: Proper Use of Internal Standards - Insights from Two Troubleshooting Case Studies

Stable isotope-labeled internal standards are widely used in laboratory-developed clinical mass spectrometry tests. An equal amount of these internal standards is added to all samples in a batch, ...
RAPS

FDA Delays Finalization of Lab-Developed Test Draft Guidance

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 ...
Business Wire

Thermo Fisher Scientific Introduces New Laboratory Developed Test to Help Transplant Patients Receive the Right Dose of Critical Anti-Rejection Medication Sooner

WEST HILLS, Calif.--(BUSINESS WIRE)--Thermo Fisher Scientific, the world leader in serving science, today announced the launch of the TacroType™ Pharmacogenetic Test, a new laboratory developed test ...
RAPS

Hamburg: Lab-Developed Tests to be Subject to Heightened Scrutiny under New Framework

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 ...
JD Supra

Laboratory-Developed Tests (LDTs) Do Not Qualify as ‘Devices’ Under the Food, Drug and Cosmetic Act

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 ...
Mena FN

Laboratory Developed Tests Market Size To Reach USD 28.31 Billion By 2035 SNS Insider

(MENAFN- GlobeNewsWire - Nasdaq) The U.S. Laboratory Developed Tests Market is projected to grow from USD 5.97 Billion in 2025 to USD 11.85 Billion by 2035, while Europe is expected to expand from USD ...
STAT

A court decision on lab-developed tests sets a dangerous precedent

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 ...
Morningstar

Clinical Labs Review Proposed Legislation To Modernize Oversight of Lab-Developed Tests Under CLIA

SALT LAKE CITY, June 16, 2026 /PRNewswire/ -- Clinical laboratories, including ARUP Laboratories, are reviewing newly introduced federal legislation to modernize oversight of laboratory-developed ...
Becker's Hospital Review

FDA wants to crack down on lab-developed tests: 3 things to know

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 ...
KSL

FDA to start regulating lab-developed tests

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