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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Keeps you up to date on the latest legal, compliance, and business developments affecting the lab industry, while offering analysis and insight to ensure your lab’s success.
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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
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....