6th October 2020 Product update: rapidmicrobiology staff writer
FDA Authorizes Four-In-One-Test for Respiratory Virus Season
Cepheid has received Emergency Use Authorization (EUA) from the US FDA for its Xpert® Xpress SARS-CoV-2/Flu/RSV kit; a rapid molecular diagnostic test for the qualitative detection of the viruses causing COVID-19, Flu A, Flu B, and RSV infections from a single patient sample.
The four-in-one test is designed for use on any of Cepheid's over 26,000 GeneXpert® Systems placed worldwide, with results delivered in approximately 36 minutes.
Cepheid's previously announced capacity expansion program, supported by parent company Danaher Corporation, was designed in part to address anticipated demand for Xpert Xpress SARS-CoV-2/Flu/RSV. Cepheid expects the first impact of the program in the fourth quarter of 2020 with additional capacity ramping through 2021.
The new EUA combination test is expected to begin shipping to US customers this week, with expected CE-IVD availability in November.
Date Published: 6th October 2020
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Note: This content has been edited by a rapidmicrobiology staff writer for style and content.
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