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Analysis and insight on key compliance, legal, and business developments affecting laboratories
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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
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
3 Thoughts on the FDA’s Final LDTs Rule
Regulatory expert Julie Ballard shares her first thoughts on the final rule for lab-developed tests and immediate steps for labs
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...
Air Force Expands Longitudinal Genomics Study
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies The Air Force Medical Service (AFMS) in partnership with the Coriell Institute for Medical Research (Camden, N.J.) have launched phase II of the longitudinal Clinical Utility Study (CUS). CUS...