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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
FDA and CMS Address LDT Regulation Before Energy and Commerce Committee
By Kelly A. Briganti, Editorial Director, G2 Intelligence Last week, the U.S. House of Representatives Energy and Commerce Committee heard testimony about oversight of laboratory developed tests (LDTs) from representatives of the U.S. Food and Drug Administration...
USPSTF Recommendations Cut PSA Testing; More Personalized Screening Called For
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Prostate-specific antigen (PSA) screening rates, along with the incidence of early-stage prostate cancer, have declined since the 2012 U.S. Preventive Services Task Force (USPSTF) recommendation to...
Circulogene Releases Dipstick Test For Tumor Analysis
By Ron Shinkman, Editor, Laboratory Industry Report Circulogene Theranostics has released a finger-stick test that allows clinicians to monitor the progression of cancer with just a drop or so of blood. The assay will analyze 10 kinds of cancer: Breast, colorectal,...
HCA Agrees to Pay $2 Million to Settle Claims of Unnecessary Lab Tests
By Kelly A. Briganti, Editorial Director, G2 Intelligence HCA Holdings, Inc. (formerly called Hospital Corporation of America) has settled health care fraud allegations relating to diagnostic testing for $2 million—including payment of damages and penalties. The...