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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Lab Industry Advisor Subscriptions Include
Analysis and insight on key compliance, legal, and business developments affecting laboratories
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Latest Articles
LDTs Rule Update: More Support for Legal Challenges Against FDA
Key clinical laboratory organizations file amicus brief, reiterating that the FDA is overstepping its authority, and its new rule would cause “irreparable patient harm”
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
CMS Slated to Close Change Healthcare Payment Program
Program meant to ease cash flow disruptions experienced by some Medicare providers and suppliers due to the cyberattack will conclude in mid-July
New Platform Helps Labs Comply with Patient Access Requirements
By Kelly A. Briganti, Editorial Director, G2 Intelligence Psyche Systems Corporation (Milford, MA), a laboratory information software company, and Luminate Health (San Francisco, CA), a provider of web-based services, have entered into a "strategic alliance" to...
Invivoscribe, Astellas Enter Into Pact for Leukemia Testing
By Ron Shinkman, Editor, Laboratory Industry Report Invivoscribe Technologies, a San Diego-based laboratory and equipment supplier, has entered into a companion testing pact with Astellas Pharma, Inc. The deal will focus primarily on developing a diagnostic test...
Update: New Study Credits Criminal Attacks as Source of Most Healthcare Data Breaches
By Kelly A. Briganti, Editorial Director, G2 Intelligence Last week, we referenced a 2014 study by Ponemon Institute that estimated the cost of a data breach to be around $200 per record in the United States, with the healthcare industry having one of the highest...
Quest Collaborates With French Researchers to Provide BRCA Variants Data
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Veracyte Obtains $40 Million in a Private Placement
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Pathway Genomics Introduces Comprehensive Colorectal Cancer Panel
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Highmark Blue Shield Will Make Metamark Assays Available to Enrollees
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Repeal of the SGR Brings Some Uncertainty to the Future Practice of Pathology
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Color Genomics Offers $249 BRCA Test
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At ACLA Meeting, Relief and Resolve in the Wake of Major Policy Changes
By Stephanie Murg, Managing Director, G2 Intelligence What a difference a year makes. That was the prevailing sentiment at the opening sessions of the 20th annual meeting of the American Clinical Laboratory Association (ACLA), which runs through today at the Grand...