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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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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
New Studies Question Utility of Gene Expression Testing for Cancers With Unknown Primary Site, Low-Risk Breast Cancer
From - Diagnostic Testing & Emerging Technologies
Gene expression profiling has been making inroads into clinical cancer care, with application in cancer classification, most notably with…
Compliance Perspectives: CMS Reviews PAMA Reporting Basics for Hospital Outreach Labs
From - Lab Compliance Advisor
PAMA reporting is tricky business in which mistakes and omissions carry the risk of civil monetary penalties of up to $10,000 per day. So, whether you're with…
Medical Marijuana: CBD Doesn’t Get You “High” But May Make You Fail a Drug Test
From - National Intelligence Report
Testing for marijuana isn't as simple as it used to be thanks to the increased use of cannabidiol (CBD) products. Based on oils extracted from…
FDA Watch: Agency Finalizes New Medical Device Marketing Pathway & Okays Direct Lab Reporting of PGx Test Results
From - Laboratory Industry Report
On Jan. 22, the FDA issued final guidance establishing a new alternative pathway for getting medical devices to…