FDA Clears Simplexa Group A Strep Direct Test
CE marked and assigned to moderate complexity status in the United States, the Simplexa PCR-based strep A direct test by Focus Diagnostics is now available internationally.
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NanoString and MD Anderson to Develop Multi-Omic Assays
Using NanoString’s nCounter analysis system as a platform, the partners aim to jointly discover and validate biomarker signatures for immuno-oncology and targeted therapeutics.
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Lab Informatics
In clinical labs, the application of modern lab informatics systems covers a growing range of uses.
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April 2015 Product Spotlight: Chemistry and Integrated Analyzers
Featured chemistry and integrated analyzers include the Arkray Aution Hybrid AU-4050 analyzer system from US Arkray Inc, the Advia Chemistry XPT system from Siemens Healthcare, and the Cobas 8000 analyzer series from Roche Diagnostics.
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FDA Grants Emergency Use Authorization for Ebola Diagnostic Test
Delivering results in less than 2 hours, the Xpert ebola test has been authorized for use by CLIA moderate- and high-complexity laboratories or similarly qualified non-US laboratories.
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