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
Analytics Fuel the Business of Enforcement
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Happy 50th Birthday Medicare and Medicaid!
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Hurdle for Whistleblowers Simplified in 9th Circuit
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Analytics Aid Fraud Detection Efforts, Identifying $820 Million in Improper Payments
By Kelly A. Briganti, Editorial Director, G2 Intelligence Analytics aren't valuable just for improving business. The Centers for Medicare and Medicaid Services (CMS) announced this month that its Fraud Prevention System (FPS), an "advanced analytics system," has...
Corporate Wellness Programs Expressing Interest in Genetic Testing
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Nearly half of workers diagnosed with a chronic illness receive their diagnosis through participation in a corporate wellness program, according to survey results recently released by health...
Interleukin, NYU Enter Into Deal to Develop Osteoarthritis Risk Assay
By Ron Shinkman, Editor, Laboratory Industry Report Massachusetts-based molecular laboratory Interleukin Genetics has reached an agreement with the New York University School of Medicine to develop a genetic test that would identify patients at risk for the...
OpGen Agrees to Acquire AdvanDx, Lands $6 Million Investment from Merck
By Stephanie Murg, Managing Director, G2 Intelligence In the wake of its fizzled May IPO, OpGen (Gaithersburg, Md.) is in expansion mode. The microbial genetics analysis company has agreed to acquire molecular diagnostics company AdvanDx (Woburn, Mass.) in an...
Payment Reform Efforts to Support Cancer Care Coordination, Treatment Planning
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Molecular Testing Making Strides in Melanoma Care
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Putative Loss-of-Function Variants More Common Than Thought
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