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, ...
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 ...
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Judge foils FDA plan to regulate lab-developed tests
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 ...
DENTON, Texas, April 1, 2025 /PRNewswire/ — HealthTrackRx, a leader in molecular diagnostics and named plaintiff in the lawsuit challenging the U.S. Food and Drug Administration’s (FDA) regulation of ...
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 ...
FREEHOLD, N.J., Aug. 30, 2023 (GLOBE NEWSWIRE) -- Avalon GloboCare Corp. (ALBT), a developer of innovative precision diagnostics and provider of clinical laboratory services, today announced that ...
BURLINGTON, N.C., Oct. 23, 2025 /PRNewswire/ -- Labcorp, a global leader of innovative and comprehensive laboratory services, announced today it will offer the Elecsys pTau181 test, the only blood ...
The MarketWatch News Department was not involved in the creation of this content. TacroType(TM) Pharmacogenetic Test designed to support more personalized tacrolimus dosing, assisting clinical ...
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