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
Genetic Risk Score Aids in Parkinson’s Diagnosis
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Trovagene Creates Italian Alliance to Gain Toehold in Europe
By Ron Shinkman, Editor, Laboratory Industry Report San Diego-based molecular laboratory Trovagene has established a European subsidiary that is intended to expand the capabilities of its cancer testing platforms. The Trovagene Research Institute was established in...
Vaginal Microbiome Predicts Risk of Premature Labor
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Burwell Visit to China and Korea Emphasizes US Commitment to Global Health Security
By Kelly A. Briganti, Editorial Director, G2 Intelligence This month, Secretary of the Department of Health and Human Services Sylvia Burwell visited the Chinese Center for Disease Control and Prevention during a trip to Seoul and Bejing promoting protection of...
NantOmics Acquires OncoPlex Diagnostics
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CMTP Issues Draft Framework for Covering NGS Testing
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NeoGenomics Enters Into Hospital Testing Deal With Premier
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Exosome Raises Second Round Funding, Close to Launching Cancer Tests
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Health Diagnostic Laboratory Sold at Auction
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