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Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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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
LDTs: FDA Gets Tough with Non-Approved PGx Testing Claims
From - National Intelligence Report
The FDA has apparently set its enforcement sights on Laboratory Developed Tests (LDTs) that claim to predict…
Adoption Quickening for Genomic Cancer Testing in Community Settings
From - Diagnostic Testing & Emerging Technologies
Clinicians are increasingly using genomic cancer testing in community health care settings, although there are…
Are Erratic Scheduling Practices Causing Financial Instability for Your Hourly Lab Employees?
From - Laboratory Industry Report
A study reveals that for today's hourly workforce, missing a single shift comes at a steep cost…
Explaining the Legal News: Why ACLA Court Win Boosts Chances of PAMA Pricing Relief
From - Lab Compliance Advisor
By now, you've no doubt heard the news that the American Clinical Laboratory Association (ACLA) "won" its lawsuit against…
Genetics Update: Internet Use Can Help Patients Self-Diagnose Rare Genetic Disorders
From - Diagnostic Testing & Emerging Technologies
The notion of empowering patients to take control over their own health care is particularly powerful within the realm of…
The Dx Pipeline: A Roundup of the Month’s Key New Product Launches
From - Laboratory Industry Report
Here's a summary of the key product launches announced from late July through the third week of…
Genetic Testing Fraud Prosecutions are on the Rise around the Country. Are Your Genetic Testing Practices Compliant?
By Robert Liles bio
Over the last year, a number of genetic testing fraud investigations and prosecutions have been initiated by…