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
Private Payer Reimbursement for Genetic Testing Hinges on Clinical Utility
Two revenue cycle management experts offer tips for clinical labs to improve coverage decisions for genetic tests
Electronic Prior Authorization Bill Reintroduced in Congress
For clinical labs, the proposed law could bring more consistency to test ordering
Dx Deals: Quest Makes Big North American Expansion with LifeLabs Acquisition
The roughly $1 billion deal will boost the company’s annual revenue by about 7 percent, and will give Quest a stronger presence in Canada
Loper Bright Renews Interest in the VALID Act
The US Supreme Court decision that recently overturned the Chevron doctrine is influencing potential enactment of new legislation
September 2024 Labs in Court
Recent DOJ settlements continue to focus on issues involving medical necessity and marketer compensation
What Labs Need to Know About MolDX®
How the MolDX® program works, what it covers, and how it can support better test access, use, and reimbursement in the clinical lab
Key Developments and Challenges in Laboratory Networks
The current landscape of medical laboratory networks and challenges that will need to be addressed to improve data sharing and efficiency.
Dx Deals: Outreach Deals by Quest, Labcorp Are Still Ramping Up
Though the two national players have closed dozens of such deals over the past decade, much runway for new transactions apparently remains
Electronic Device Use in the Laboratory: The Keys to Safety
Three main risks to consider when it comes to personal electronic devices, and how to safely incorporate their use in the laboratory
Considering the Impact of Digital Pathology on Recruitment Efforts
How might a modestly sized lab or pathology group harness technology to address their recruitment needs?
