FDA Watch: Agency Takes Steps to Downgrade Some Nucleic Acid-Based Tests to Class II
The change is expected to dramatically cut the costs of developing new tests
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Articles and Reports
Genetic Testing Kickback Scheme Results in 46-Month Prison Term
Federal prosecutors continue to target situations where third-party recruiters influence test ordering
Dx Deals: Labs Exploring Cryptocurrency Share Their Plans
Know Labs and ProPhase Laboratories discussed plans that in part involve digital currencies
Attention Lab Directors: Four CLIA Updates from the Past Year to Examine
CMS tweaked its CE, documentation, and on-site visit requirements for directors
Prospective Changes to HIPAA Rules Would Affect Clinical Labs
With new modifications to HIPAA potentially on the horizon, we hear from experts on HHS' proposal
FDA Watch: CND Life Sciences Wins Breakthrough Device Designation for Skin-Based Neurodegenerative Test
The Syn-One assay can diagnose multiple conditions without needing a lumbar puncture
The Cost of Not Keeping Legacy Clinical Laboratory Technology Up to Date
By not modernizing legacy systems and software, labs risk incurring hidden costs
Dx Deals: Labcorp and Roche Enter into Pacts to Distribute Alzheimer’s Tests, Digitize Slides
The technology developed by Roche in recent years seems a good fit for Labcorp’s testing services
Clinical Lab Training Documentation Becomes More Important with CMS Revision
Third-party verification of lab personnel experience is now a CLIA requirement
PAMA Cuts to Clinical Labs Get Brief Delay Through January 30, 2026
Bill that ended government shutdown includes provision to hold off PAMA cuts
2026 Predictions for Clinical Labs: AI, Audits, and Increased Enforcement
How clinical laboratories should prepare for the next wave of oversight in the new year
The Most Common Chemical Waste Management Mistakes for Clinical Labs to Avoid
How laboratory staff can steer clear of common mistakes when handling and storing chemical waste
Dx Deals: Sonic Healthcare Buys East Coast Lab in First Such US Acquisition Since 2021
Australian firm has grown its overseas operations dramatically in the past decade, except in America
