Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
Troubled Calloway Laboratories Shut Its Doors
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Boston Heart Diagnostics CEO Pushes for More Holistic Role for Labs
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FDA Approves Quest Influenza Test
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OHSU Collaborates With Swedish Firm to Develop Pancreatic Cancer Assay
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Growth in BRCA Testing Not Met With Recommended Use of Pretest Counseling
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Most U.S. women undergoing BRCA genetic testing do not receive recommended genetic counseling, according to a study published Oct. 1 in JAMA Oncology. The finding of wide variability in referral...
Millennium Settles False Claims Allegations for $256 Million
By Kelly A. Briganti, Editorial Director, G2 Intelligence Seeking a fresh start, Millennium Health (San Diego, Calif.) announced it has agreed to pay three different settlement amounts and is entering into a corporate integrity agreement with the Department of...
Commonwealth Laboratories and Quest Collaborate on Distribution of IBS test
By Ron Shinkman, Editor, Laboratory Industry Report Commonwealth Laboratories has entered into a distribution agreement with Quest Diagnostics regarding its test for irritable bowel syndrome (IBS). Under the terms of the deal, physicians will be able to order the...
Avoid IRS, DOL Scrutiny: Properly Characterize Independent Contractors and Employees
By Kelly A. Briganti, Editorial Director, G2 Intelligence For flexible staffing, it may be appealing to hire independent contractors. But make sure your arrangement is truly an independent contractor arrangement and not employment. Just the label you give it isn't...
33rd Annual Lab Institute Highlights Opportunities and Challenges Ahead for the Industry
By Kelly A. Briganti, Editorial Director, G2 Intelligence Throughout two and a half days on Capitol Hill, laboratory insiders debated and shared knowledge, insight and concerns about compliance issues, new business challenges and the latest regulatory changes...
Theranos Under Fire After Wall Street Journal Coverage
By Ron Shinkman, Editor, Laboratory Industry Report Theranos, the California-based laboratory startup that claims it has revolutionized testing by being able to run assays with just a few drops of blood, came under sharp scrutiny late last week by the Wall Street...