How the LDT Final Rule’s Exemptions Apply to Oncology Labs
Regulatory expert explores whether any exclusions might benefit cancer laboratories trying to navigate upcoming compliance deadlines
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FDA Watch: FDA Approves Enhanced Cologuard Cancer Test
Test maker Exact Sciences says it expects Cologuard Plus to cut false positives by more than 30 percent
What Labs Need to Know About Reporting Adverse Events to the FDA
Understanding the process and implementing proper procedures is the key to ensuring compliance when reporting such events
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.
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.
March 2023 Labs in Court: Labcorp Wins One, Settles Another
In this month’s roundup of cases involving labs, Labcorp gets one lawsuit tossed and settles another.
Six Steps for a Bloodborne Pathogens Exposure Determination
The first phase in protecting your staff is to carry out an exposure determination to figure out which of your workers are at risk.
Model Code of Conduct for Laboratory Sales and Marketing
A template for creating a general code of conduct that sets out broad parameters and ground rules for compliance.
Six Lab Sales and Marketing Compliance Problem Areas and How to Address Them
It’s imperative for labs to establish and maintain an active corporate compliance program that augments the actual scientific testing.
FDA: EUAs for COVID-19 Lab Tests Will Continue after PHE Ends
Agency says it will continue to have authority to clear new lab tests and other COVID-19 products on an emergency basis even after the PHE ends.
