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FDA Clearance for DiaSorin's New SimplexaGroup B Strep Direct


DiaSorin have received FDA clearance for its new SimplexaGroup B Strep Direct recently launched in the European market. Designed for use on the LIAISON MDX instrument, the new test enables the direct detection of Group B Streptococcus DNA.

The new assay can replace traditional culture testing methods and features an efficient and fast workflow. 

“After the launch few weeks ago in Europe, now the Simplexa Group B Strep Direct is available also in the United States.” said Michelle Tabb, Chief Scientific Officer at DiaSorin Molecular LLC. “Our Group continue to support hospitals and clinical labs worldwide to provide excellent patient care through high-quality molecular assays also in the women’s health testing market all over the world.”


      

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Date Published: 4th December 2018

Source article link: DiaSorin Molecular Diagnostics


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