Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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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
Court Decides “Absurd” Is Worse than “Potentially Unworkable” When Interpreting 60-Day Repayment Rule
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Changes in Cervical Cancer Screening Impact Chlamydia Testing
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Biocept, UC Irvine to Collaborate on Liquid Biopsies
By Ron Shinkman, Editor, Laboratory Industry Report San Diego-based Biocept will collaborate with the University of California at Irvine to study differences in biomarkers in blood-based specimens versus invasive tissue samples. The intent, officials say, is to be...
X Chromosome Marker Could Diagnose Serious Mental Disorders
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Drones Feasible for Lab Specimen Delivery
By Lori Solomon, Editor, Diagnostic Testing & Emerging Technologies Unmanned Aerial Systems (UAS or drones) could potentially be used to transport clinical laboratory specimens. Transportation of laboratory specimens via small UASs does not affect the accuracy of...
Military Could Use Hand-Held Spectroscopy for Pathogen Detection
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FDA Announces Informatics Community to Support Precision Medicine Initiative
By Kelly A. Briganti, Editorial Director, G2 Intelligence The U.S. Food and Drug Administration (FDA) has announced the development of precisionFDA, "an informatics community and supporting platform" to assist efforts to maximize the potential of genetic...
Cord Blood CEO Raises Questions About Physician Payments
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Harmonyx Releases New Tests for Gauging Painkillers
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Could Drones Play a Role in Lab Operations?
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