SDPA Announces Clinical Practice Guidelines Addressing the Use of Laboratory Testing in Diagnosing Alopecia

SDPA releases its first Clinical Practice Guidelines on alopecia testing, advancing evidence-based care and strengthening the ...
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 ...
JD Supra

FDA to rescind laboratory developed test rule

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 ...
Tyler Morning Telegraph

HealthTrackRx Applauds Court Ruling to Vacate FDA’s Laboratory-Developed Test (LDT) Rule

“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 ...
Healthcare Dive

Texas judge overturns FDA’s lab developed test regulation, siding with industry groups

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 ...
Morningstar

ADLM commends federal court's decision to vacate the FDA's final rule regulating laboratory developed tests

These tests are typically not advertised or sold as kits to other testing facilities. The only labs that are allowed to perform laboratory developed tests are those that are considered high-complexity ...
Hosted on MSN

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 ...
FierceBiotech

Federal judge blocks FDA's regulation of lab-developed tests

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 ...
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 ...
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 ...
Seeking Alpha

Quanterix Accelerator Laboratory Awarded Rigorous New York State Clinical Laboratory Permit

BILLERICA, Mass.--(BUSINESS WIRE)-- Quanterix Corporation (QTRX) (NASDAQ: QTRX), a company fueling scientific discovery through ultrasensitive biomarker detection, today announced the New York State ...