FDA Will Not Appeal Ruling Against LDT Regulation, Giving a Big Victory to Labs
The legal strategy of the ACLA—and some political luck—prevailed in the lawsuit against LDT oversight
Author Information
Ron Shinkman
Ron Shinkman is a veteran journalist and editor, with more than 20 years of experience in the healthcare business realm. He served as Los Angeles bureau chief of Modern Healthcare and also wrote for the Los Angeles and Orange County Business Journals.
Posts by the Author
Dx Deals: Labcorp Continues Dealmaking with Incyte Asset Acquisition in Washington State
The majority of Labcorp’s revenue growth in the first quarter came from clinical lab acquisitions
FDA Approves Teal Wand as First At-Home Cervical Cancer Screening
Teal Health, the company manufacturing and distributing the test, says thousands of women are already on a waiting list for the assay
Dx Deals: Labcorp and BioReference Health Agree on $225m Sale of Some Assets
Labcorp will acquire oncology-related clinical tests services from BioReference’s parent company, OPKO Health
Diagnostics Pipeline: FDA Approves Visby Medical’s Over-The-Counter Women’s Sexual Health Test
It’s the first PCR-based sexually transmitted infection test platform for at-home use
CDC-nirCLIA-lcaCLIA-nirCMS-lcaCMS-lirCMS-nirEssentialFDA-lcaFDA-lirFDA-nirLab Industry AdvisorRon Shinkman
HHS Suddenly Dismantles CLIAC After 33 Years
The board was eliminated as part of a sweeping reordering of the Department of Health and Human Services
FDA Watch: CDRH Budget May Not See Steep Cuts in FY 2026
A leaked budget document for the next fiscal year suggested non-user fee funding may be up slightly compared to recent years.
Dx Deals: Quest Diagnostics M&A Centers on Precision-Focused Approach
Recent inroads into testing of water for dialysis equipment illustrates Quest’s expanded scope with deals
Diagnostics Pipeline: Savara Introduces Blood Test to Detect aPAP, a Rare Lung Disorder
Savara’s ClearPath assay needs just a few drops of blood to test for aPAP, a condition that can be difficult and invasive to diagnose
FDA Watch: DOGE Changes at FDA Upend Approval Processes, Observers Say
Pre-submission and Q-Submission meetings apparently have been halted, for now
