The U.S. trade group representing laboratory companies and test manufacturers is suing to block the FDA from increasing its oversight of lab-developed tests, saying the agency overstepped its ...
The U.S. Food and Drug Administration (FDA) plans to rescind its laboratory developed test (LDT) rule dated May 6, 2024. The rule would have regulated LDTs as in vitro diagnostic products (IVDs) and ...
On March 31, 2025, Judge Sean D. Jordan of the U.S. District Court for the Eastern District of Texas issued an opinion and judgment in American Clinical Laboratory Association v. FDA (“ACLA v. FDA”), ...
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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 ...
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, ...
SEATTLE, Jan. 07, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into ...
A Texas federal court on Monday struck down the Food and Drug Administration’s new rule regulating laboratory developed tests as medical devices in a victory for the clinical lab industry. Judge Sean ...
Labcorp® Plasma CompleteTM offers oncologists a highly sensitive and specific genomic profiling solution from a simple blood draw Labcorp Plasma Complete detects genomic alterations in ctDNA across ...
A group representing clinical labs across the country sued the Food and Drug Administration on Wednesday over the agency’s plan to actively regulate lab-developed tests. The suit, filed in a Texas ...
“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 ...
BILLERICA, Mass.--(BUSINESS WIRE)-- Quanterix Corporation (QTRX) (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced the New York State ...
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