New Saliva-Test for ...
"Error-proofing" and...
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.
Tags:
Date Published: 6th October 2020
Source article link: View
Note: This content has been edited by a rapidmicrobiology staff writer for style and content.
New Saliva-Test for COVID-19 Diagnosis
"Error-proofing" and "Future-proofing": Updating the
Over 7,000 microbiology professionals get our weekly eNewsletter - subscribe now and find out why!
LATEST MICROBIOLOGY NEWS
- Be Prepared this Season with Puritan® Specimen Collection Supplies
- Consistent Quality for At-home or Point-of-care Swab Testing
- Advance Your Science With Custom Certified Reference Materials
- Efficient and Safe Ways to Transfer Materials into Controlled Areas
- INTEGRA's Innovative Modules Simplify Magnetic Bead Purification Workflows
- The Marketing Solution for Global Microbiology Brands for Over 20 Years
- Get Accurate Species Level Microbial ID with VITEK® MS PRIME
- USP <1223> Validation Confirms BAMS as a Reliable Alternative Method
- AI Automated Reading of Environmental Monitoring Contact Plates With APAS® Independence
- Environmental Monitoring and Bioburden Control in Light of Annex 1
MICROBIOLOGY EVENTS
- Growth Direct® Day 2024
- Practical Microbiology – Intermediate
- Pharmig’s 32nd Annual Conference
- From Challenge to Change: Implementing Digital and Automation Projects in Pharma
- The Use of Fourier Transform Infrared (FTIR) Spectroscopy in the Probiotic Field
- Microbiological Wastewater Monitoring
- Confience Webinar - Steps to Selecting the Right LIMS Partner
- PharmaLab Congress and Exhibition 2024
- Alternative and Rapid Microbiological Methods
- Setting Shelf life: How To Do It Better