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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Struggling with Staying Informed? In the fast-paced world of diagnostic medicine, staying updated with the latest legal, compliance, regulatory, and industry insights is crucial. Yet, finding reliable and comprehensive information can be overwhelming and time-consuming.
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
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
Physician Practice Agrees to $3.2 Million Settlement of Stark and False Claims Allegations
By Kelly A. Briganti, Editorial Director, G2 Intelligence Laboratory services are at the center of another False Claims Act settlement—this time in an arrangement involving a dermatology practice and its dermatopathology laboratory. A Georgia-based dermatology...
Tumor-Only Sequencing Plagued by False Positives
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Many of the genetic changes detected by sequencing tumor tissue are not actually associated with the cancer, but reflect inherited germline mutations that are also present in non-cancer cells of...
Millennium Pays Ameritox $8.6 Million for Patent Infringement
By Christopher P. Young, Editor, G2 Compliance Advisor In an April 21 award of damages in a patent infringement lawsuit filed by Ameritox and Marshfield Clinic against Millennium Health (MH), formerly Millennium Laboratories, jurors decided that $8,652,760 would...
Study Says Cleveland HeartLab Test Can Cut Heart Attacks, Strokes
By Ron Shinkman, Editor, Laboratory Industry Report A new study by the Cleveland HeartLab and the personalized medicine firm MDVIP concluded that the former's cardiac inflammation assay could significantly reduce the occurrence of heart attacks and strokes....