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The 15-minute digital lateral flow immunoassay originally obtained Emergency Use Authorization from the US FDA in 2020.
The development marks a shift up the value chain for labs and could prove a meaningful revenue stream for providers able to ...
The company's platform combines microfluidics, cytology, and artificial intelligence-based image analysis for the identification of mild-to-severe dysplasia.
The test, which Santa Maria, California-based Hardy distributes in the US under a license from NG Biotech, is designed to detect CTX-M enzymes.
Through clinical trials, partnerships, and economic studies, a crop of test developers is trying to prove the value of their ...
The Uppsala University spinout aims to use its SuperRCA mutation detection technology for applications including molecular residual disease monitoring.
The company reported difficulties ahead for its immunodiagnostics business in China in the wake of changes in late April related to the country's Diagnosis-Related Groups (DRG) policy on hospital lab ...
Last week, readers were most interested in a story about Roche's blood-based Alzheimer's test getting CE marking.
An assessment of the documentation for 30 over-the-counter diagnostic tests found none met the current regulatory standards.
The deal brings together Promega's Maxwell automated nucleic acid extraction system and Longhorn's viral molecular transport media.
The company raised its full-year revenue guidance slightly due to changing foreign exchange rates but lowered its full-year EPS guidance.
China sales were down 26 percent in the first half of the year due to volume-based procurement programs and healthcare pricing reforms in China.
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