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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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
Illumina Enters Into Prenatal Testing Pact With Chinese Firm
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PathGroup Introduces Molecular Cancer Panels
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Midyear Update to OIG Work Plan Targets Laboratory Testing
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The Art of Appeals: Don't Give Up Too quickly When a Payer Denies Your Claim
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Don’t Overlook Varying State Requirements Applicable to Independent Clinical Labs
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U.S. Supreme Court Upholds Nationwide Individual Insurance Subsidies
By Ron Shinkman, Editor, Laboratory Industry Report The United States Supreme Court ruled Thursday to maintain income-based subsidies that allow millions of Americans to purchase individual health insurance policies from the federal healthcare.gov insurance...
Compliance Officers Need Increased Role in Strategic Decisionmaking
By Kelly A. Briganti, Editorial Director, G2 Intelligence PricewaterhouseCoopers (PwC) announced its fifth annual State of Compliance Survey (2015) indicates corporate compliance officers (CCOs) need to be more involved in strategic decisionmaking—as only one-third...
NCI-MATCH to Launch Simultaneous Trials of 20+ Targeted Therapies
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies The precision medicine trial NCI-MATCH (National Cancer Institute-Molecular Analysis for Therapy Choice) will open for patient enrollment in July. The multicenter trial will evaluate the...
Novel Marker Shows Promise for Early Detection of Pancreatic Cancer
By Stephanie Murg, Managing Director, G2 Intelligence Tiny particles known as exosomes may be a powerful cancer screening and diagnostic tool—the trick is detecting and isolating those that are derived from cancer cells. Researchers at the University of Texas MD...
ABIM Grant Awarded to Reduce Unnecessary Pap Tests
By Kelly A. Briganti, Editorial Director, G2 Intelligence In keeping with the national focus on reducing unnecessary medical care and getting the right test to the right patient at the right time, the American Board of Internal Medicine (ABIM) Foundation awarded a...