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 ...
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 ...
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 ...
“This ruling affirms what we and our colleagues across the industry have long maintained: the FDA lacks the legal authority to regulate LDTs,” said Martin Price, Executive Chairman & CEO of ...
A federal judge in Texas has blocked the FDA’s plans to bring laboratory-developed tests under the same regulations it uses to oversee other in vitro diagnostics and medical devices—saying the agency ...
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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