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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
Analytics Aid Fraud Detection Efforts, Identifying $820 Million in Improper Payments
By Kelly A. Briganti, Editorial Director, G2 Intelligence Analytics aren't valuable just for improving business. The Centers for Medicare and Medicaid Services (CMS) announced this month that its Fraud Prevention System (FPS), an "advanced analytics system," has...
Corporate Wellness Programs Expressing Interest in Genetic Testing
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Nearly half of workers diagnosed with a chronic illness receive their diagnosis through participation in a corporate wellness program, according to survey results recently released by health...
Interleukin, NYU Enter Into Deal to Develop Osteoarthritis Risk Assay
By Ron Shinkman, Editor, Laboratory Industry Report Massachusetts-based molecular laboratory Interleukin Genetics has reached an agreement with the New York University School of Medicine to develop a genetic test that would identify patients at risk for the...
OpGen Agrees to Acquire AdvanDx, Lands $6 Million Investment from Merck
By Stephanie Murg, Managing Director, G2 Intelligence In the wake of its fizzled May IPO, OpGen (Gaithersburg, Md.) is in expansion mode. The microbial genetics analysis company has agreed to acquire molecular diagnostics company AdvanDx (Woburn, Mass.) in an...
Theranos Receives First FDA Clearance, Inks Deal with Capital BlueCross
By Stephanie Murg, Managing Director, G2 Intelligence July is proving to be a month of milestones for Theranos (Palo Alto, Calif.). The company recently received its first FDA clearance—for its herpes simplex virus-1 (HSV-1) IgG assay—and announced a partnership...
White House Releases Precision Medicine Privacy Principles
By Kelly A. Briganti, Editorial Director, G2 Intelligence While promoting a personalized approach to medicine which involves more sharing of data, the Obama administration isn't neglecting the need to protect privacy when it comes to health information. The White...