Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
Best practices and expert insight to help lab professionals comply with regulations and identify strategic trends in business and technology
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
The Future of Laboratory-Developed Tests
Comments on the FDA’s proposed rule to regulate LDTs as in vitro diagnostic devices reveal mixed reactions.
AI in Healthcare: What Do Recent Developments Mean for Labs?
Genialis CEO and co-founder Rafael Rosengarten, PhD, discusses key 2023 AI developments and what they could mean for laboratories.
Diagnostics Pipeline: FDA Opens Path for Blood Tests Assessing Genetic Cancer Risk
First marketing authorization of a blood test assessing genetic variants related to cancer opens the door for clearance of similar tests.
Advancements in Antimicrobial Susceptibility Testing: Part 1
A brief overview of antimicrobial susceptibility testing, current methods used, and new methods on the horizon.
Polygenic Risk Scores: A Cardiovascular Conundrum
Polygenic risk scores may offer new screening and risk stratification options for cardiovascular disease—but how valuable are they?
Expert Q&A: Enhancing Clinical Labs through Advanced Data Analytics
Lisa-Jean Clifford of Gestalt Diagnostics, discusses key trends, challenges, and solutions in data analytics for clinical labs.
Lost Ground: Cancer Screening in the COVID-19 Era
A pandemic-related drop in cancer diagnoses could spell long-term trouble for patients and providers.
Patient-Centric Strategies for Labs: A Roadmap for 2024
Five strategies for lab leaders to focus on to tackle the challenges of today and ensure future success.
OSHA Citations for Hazardous Chemicals in Labs May Stem from Subpar Training
Standard 1910.1450 requires labs to have a chemical hygiene plan.
Laboratory Safety: A Universal Right
Approaching laboratory safety from a diversity, equity, inclusion, and accessibility perspective.
