The global diagnostics manufacturer plans to transform its West Virginia sales and distribution site into a manufacturing hub for next-generation diagnostic products.
Empowered patients, inadequate healthcare coverage, and systemic pressure are factors influencing doctors’ test orders and intensifying doctors’ collaboration with dwindling clinical laboratory staff.
A recent court ruling excluding LDTs from FDA regulation highlights the urgent need for the diagnostics industry to modernize oversight.
COLA Inc. is rebranding as the Commission on Laboratory Accreditation (COLA) to better reflect its mission promoting laboratory excellence.
A federal court ruled in favor of AMP, striking down the FDA’s attempt to regulate laboratory-developed tests (LDTs) as medical devices.
Lot-to-lot reagent inconsistencies can have significant effects on patient test results.
bioMérieux is acquiring the assets of Day Zero Diagnostics to enhance its capabilities in NGS and rapid infectious disease diagnostics.
Scientists have documented a notable case of antibiotic resistance evolving within a critically ill patient during treatment for an E. coli bloodstream infection, providing genomic evidence of how drug resistance can emerge in real time.