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
CMS Introduces Next Generation of ACOs
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Latest Advisory Opinion Has Double Trouble for Laboratories
By Christopher P. Young, Editor, G2 Compliance Advisor A long standing issue in the laboratory industry is once again under scrutiny as the result of a U.S. Department of Health and Human Services' Office of Inspector General (OIG) Advisory Opinion (AO 15-04)...
BCBS, U of Michigan Partner to Optimize Molecular Test Utilization
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Blue Cross Blue Shield (BCBS) of Michigan and the University of Michigan Health System are collaborating with physicians and laboratories across the state to improve molecular testing...
Agena Bioscience Launches Testing Platform For Non-Small Cell Lung Cancer
By Ron Shinkman, Editor, Laboratory Industry Report San Diego-based Agena Biosciences has released a new testing platform that provides a quick and accurate identification of variations in most non-small cell lung cancers. The platform, known as the LungFusion...
AMP Weighs In on Regulation of Next-Generation Sequencing
By Stephanie Murg, Managing Director, G2 Intelligence As the U.S. Food and Drug Administration (FDA) evaluates its role in regulating next-generation sequencing (NGS)-based diagnostic tests, a range of stakeholders have responded to the agency's request for...
HHS Establishes Another Initiative Promoting Value-Based Reimbursement and Health Care Delivery
By Kelly A. Briganti, Editorial Director, G2 Intelligence The U.S. Department of Health and Human Services (HHS) launched a new resource last week to further the goal of value- and quality-based reimbursement. The Health Care Payment Learning and Action Network...
Theranos, Cleveland Clinic Enter Into Strategic Relationship
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ACMG, CAP, AMP Develop Gene Variant Diagnostic Guidelines
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BioReference, Foundation Medicine Report Strong Sales Growth
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Does Quest’s New CDC Pact Signal Bigger Shift Toward Public-Private Health Initiatives?
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