Keep Informed on Legal and Compliance Developments Affecting Diagnostic Labs
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Analysis and insight on key compliance, legal, and business developments affecting laboratories
- Updates on changes to regulations
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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”
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)...
OIG Gives Green Light to Employee Tuition Reimbursement Benefits
Could paying the tuition costs of employees seeking certification put you at risk of violating the AKS?