The agency cleared more than a dozen assays and instruments for microbiology, molecular biology, clinical chemistry, and other testing.
Last week, readers were most interested in a story about an allegation that Invitae illegally shared patients' genetic data.
NEW YORK – Proxim Diagnostics has finalized the design and development of its handheld point-of-care immunoassay instrument and cartridge and is aiming to make research-use-only and US Food and Drug ...
NEW YORK – OraSure Technologies this week submitted a next-generation Ebola virus test to the US Food and Drug Administration via the agency's Emergency Use Authorization pathway, a company ...
NEW YORK – A new European diagnostics network has been initiated to support the development of new tools for infectious disease detection and diagnosis. Called the Pan European One Health Network for ...
NEW YORK – Grail shareholders have filed a complaint with the US District Court for the Northern District of California alleging that Grail and three of its executives violated federal securities laws ...
NEW YORK – Geneoscopy announced on Tuesday that its ColoSense test for colorectal cancer screening has received coverage from the US Centers for Medicare and Medicaid Services. The stool-based RNA ...
NEW YORK – In a decision handed down on Tuesday by the US District Court for the District of Delaware, Guardant Health dodged trebled damages in a patent infringement case involving TwinStrand ...
NEW YORK – NeoGenomics said Monday after the close of markets that it has begun a private offering of $275 million of convertible senior notes. The company said it plans to use proceeds from the ...
Sysmex has launched its HISCL instrument and two blood-based Alzheimer's disease biomarker tests in Europe. The p-Tau217 test and Aβ42/40 ratio assay are research-use-only and CE-IVD marked. The tests ...
Cepheid showcased the Omni, spotlighted in the pic, at AACC in 2015, staging different scenarios where the platform could be used. NEW YORK – Seven years after a splashy — if somewhat eerie — debut at ...
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