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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
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...
FDA Issues Report Citing Case Studies It Argues Supports Need for More Oversight of LDTs
By Kelly A. Briganti, Editorial Director, G2 Intelligence The U.S. Food and Drug Administration (FDA) released a 30-plus page report yesterday detailing case studies it says demonstrate the need for the FDA to abandon its policy of enforcement discretion and...