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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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
Quest and Walmart Team Up to Provide Easier Access to Lab Tests
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Study Details Proof-of-Concept for COVID-19 Detection via Saliva Screening
SANTA CLARA, CA — Agilent Technologies Inc. announced Feb. 23 that researchers from the QIMR Berghofer Medical Research Institute in Brisbane, Australia, collaborated with Agilent experts on a proof-of-concept FTIR-based saliva COVID-19 testing workflow using...
COVID-19 Infection Detected in Breath Tests
Traces of the SARS-CoV-2 coronavirus that causes COVID-19 can be detected in microscopically small fluid droplets exhaled during a very short time span. This is the finding of a new study from the University of Gothenburg. The measurement was carried out primarily...
US FDA Approves FoundationOne®CDx as a Companion Diagnostic for KEYTRUDA®
CAMBRIDGE, MA — Foundation Medicine, Inc. announced on Feb. 21 that it received approval from the U.S. Food and Drug Administration (FDA) for FoundationOne CDx to be used as a companion diagnostic to identify patients with Microsatellite Instability High (MSI-H)...
Researcher Loses Reprisal Dismissal Claim
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Lab Company Owners Indicted for False Billing
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Eight Pay $1.1 Million to Settle Lab Test False Billing Charges
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Magazine Ad Doesn’t Bar Suit for Fraudulent Rewards Program Discounts
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Labs In Court: A roundup of recent cases and enforcement actions involving the diagnostics industry
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Rule Doesn’t Bar Attorney’s Fees for Subsequent Whistleblower
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