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
- Updates on changes to regulations
- Healthcare-related laws
- FDA approvals
- Business deals in the diagnostics space, and more
Latest Articles
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
Russian Invasion Means Labs Must Be on High Alert for Cyberattacks
Russia’s invasion of Ukraine may have a direct impact on your lab. The American Hospital Association (AHA) just issued a security alert warning hospitals and health systems to be on guard for Russian cyberattacks. The Russian military has previously used...
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)...