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, ...
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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 ...
MADISON, Wis., September 10, 2025 — Exact Sciences Corp. (Nasdaq: EXAS), a leader in cancer diagnostics, today announced the launch of the Cancerguard™ test, a new multi-cancer early detection (MCED) ...
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