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 ...
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 ...
Tyler Morning Telegraph

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

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 ...
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 ...
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 ...
The National Law Review

In Landmark Ruling, Eastern District of Texas Strikes Down FDA’s Final Rule Regulating Laboratory Developed Tests

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Becker's Hospital Review

Lab-developed test industry predicted to reach $7B by 2028

The market for lab-developed tests, now worth $4.5 billion globally, is expected to see 7 percent compound annual growth through 2028, according to a new Research and Markets report. The report ...
Labroots

Challenges of Establishing Laboratory Developed Tests

Historically, developing a molecular test within a clinical laboratory has been perceived as a complicated and laborious process. In this webinar, we aim to dispel common misconceptions of laboratory ...
The National Law Review

FDA Sued Over Laboratory Developed Tests Final Rule

We collaborate with the world's leading lawyers to deliver news tailored for you. Sign Up for any (or all) of our 25+ Newsletters. Some states have laws and ethical rules regarding solicitation and ...
Seeking Alpha

Bionano Laboratories Announces Publication of the Analytical Validation of its OGM-Based Laboratory Developed Test for Hematological Malignancies and Additional Multi-Site ...

SAN DIEGO, Dec. 12, 2023 (GLOBE NEWSWIRE) -- Bionano Laboratories today announced the publication of a study covering the analytical validation of its laboratory developed test (LDT), marketed as ...
Business Wire

Thermo Fisher Scientific Introduces New Laboratory Developed Test to Help Transplant Patients Receive the Right Dose of Critical Anti-Rejection Medication Sooner

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 ...