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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
New FDA LDTs Guidance Offers Useful Summary, But Questions Remain
Recently released document for small labs offers a more digestible version of the final rule requirements but still lacks key details
Weekly Enforcement Report: All Quiet on the Laboratory Front
Though labs were again absent from recent key enforcement actions, sentences were handed down in other healthcare-related cases.
Amazon Closes One Medical Acquisition but FTC Intervention Looms
The deal closed Feb.22, but the FTC has expressed concerns about the acquisition and Amazon’s business practices in general.
What COVID-19 Labs Must Do to Prosper in a Post-Pandemic World
With COVID-19 testing demand all but dried up, labs will have to make—or at least contemplate making—significant changes to their business.
What Happens to COVID-19 Tests after the EUA Pipeline Closes Down?
Companies in the COVID-19 diagnostic products market will need to decide whether to wind down their EUA-based investments.
COVID-19 Losses Take a Toll on Q4 Earnings—but It Could Have Been Worse
Though Q4 earnings in the lab industry took a beating as predicted, the earnings picture wasn’t nearly as bleak as many had feared.
UnitedHealthcare Expands Coverage of Genetic Cancer Tests
The health plan issued a new policy expanding coverage of molecular genetic tests for personalized cancer diagnosis, prognosis, and treatment.
Partnership to Promote Multi-Ancestry PRS Breast Cancer Testing
Genomics software developer Allelica to collaborate with Taiwanese precision medicine firm to develop a multi-ancestry breast cancer test.
Lab Industry Earnings Take a Beating in the Fourth Quarter
Drying COVID-19 testing demand drove revenues down, but not as much as expected.
How to Reduce Liability Risk for Lab Sales and Marketing
A code of conduct for sales and marketing staff is essential to allow staff to do their jobs while avoiding liability risk.
How to Explain the Current State of EKRA to Your Lab Executives
How to explain the current state of EKRA to your lab executives.