Organization

UK's NICE to Accelerate Assessment of Genedrive Test

Elevated Antibody Levels Identified in Patients With Severe Chronic Fatigue Syndrome

Congress to Pass FDA User Fee Bill Without VALID Act, Again Putting Aside LDT Regulation

FDA Allowed Problematic COVID-19 Tests on the Market Due to Agency's EUA Approach, HHS OIG Finds

UPDATE: FDA Urges Work on Monkeypox Assays, Including OTC MDx Tests

Sophia Genetics Partners With MSK on Clinical Decision Support, Boundless Bio on ecDNA Detection

OraSure Technologies HIV Self-Test Selected for CDC Program

FIND, Curetis Ink R&D Collaboration Agreement

Roche Gets FDA 510(k) Clearance for New Cobas Instrument

Florida Man Pleads Guilty to Cancer Genomic Testing Schemes, to Pay $97.4M in Restitution

DxTerity Gets New York State Authorization for Systemic Lupus Erythematosus Test

Rapid Antigen Tests Effective for SARS-CoV-2 Variants, Study Finds

Tasso Blood Collection Product Gets FDA 510(k) Clearance

Ambry Genetics Settles Class Action Lawsuit Over 2020 Data Breach for $12.3M