Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
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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Point-of-Care Tests Likely to Become Bigger Factor in Lab Business Moving Forward
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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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Shift to Gene Panels to Assess Hereditary Cancer Risk Forges Ahead
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies A virtually unlimited number of genes tied to hereditary cancer risk can be simultaneously assessed in commercially available tests given both advances in technology and the Supreme Court's...
Two FDA Workshops Focus on Precision Medicine Issues
By Kelly A. Briganti, Editorial Director, G2 Intelligence Building on discussions started in February this year, the FDA has announced two workshops it will be holding this fall regarding next-generation sequencing standards and use of databases to establish...
Trovagene Develops Urine-Based Liquid Biopsy Test for Lung Cancer Patients
By Ron Shinkman, Editor, Laboratory Industry Report San Diego-based genomic laboratory Trovagene is developing an unconventional approach to liquid biopsies for lung cancer patients, relying on specimens of urine rather than blood. According to Trovagene's...