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Cepheid Announces Development of Rapid Four-in-One Combination Test for SARS-CoV-2, Flu A, Flu B and RSV

Cepheid’s GeneXpert® System: Fast, Accurate, Easy PCR Results.

Scalable Testing for infectious diseases such as COVID-19, Flu A/B RSV, Norovirus, CPE and more, anywhere, anytime.

Cepheid recently announced the development of a next-generation test to assist global efforts in the fight against the spread of COVID-19 during the upcoming respiratory virus season. The Xpert® Xpress SARS-CoV-2/Flu/RSV four-in-one test is expected to deliver qualitative detection of SARS-CoV-2, Flu A, Flu B and RSV from a single patient sample. The test is designed for use on any of Cepheid's more than 25,000 GeneXpert Systems placed worldwide, with results expected in approximately 45 minutes, and a hands-on time of <1 minute. Cepheid expect Xpert Xpress SARS-CoV-2/Flu/RSV to be available in advance of the 2020-2021 Northern Hemisphere respiratory season.

Anywhere patients need care, Cepheid’s GeneXpert System delivers 24/7 laboratory quality, random access and on-demand answers. Cepheid’s flexible solution enables a standardised platform in both centralised and decentralised testing locations for optimised diagnostics access and improved patient pathways and management. GeneXpert Systems can be configured with a varying number of modules, or test bays, to meet the volume requirements of any setting. Smaller GeneXpert Systems are configured with 2 or 4 modules – meaning up to four different tests can be run at one time. Our largest GeneXpert System is configured with up to 80 modules – meaning as many as 80 tests can operate independently at any given time with a capacity of about 2,000 tests per day*.

Visit us at www.cepheid.com/coronavirus for the latest updates on our SARS-CoV-2 tests.

*Cepheid internal study based on 30 minute test results.

Have you validated this method, if so, how and what were the results of the validation?

All 30 currently available Xpert assays for the GeneXpert System are CE marked, including our current Xpert Xpress Flu/RSV and Xpert Xpress SARS-CoV-2 assays, providing highly accurate and rapid results within 30 and 45 minutes respectively.

Cepheid plans to pursue the US FDA Emergency Use Authorization (EUA) regulatory pathway followed by CE-IVD registration for the Xpert Xpress SARS-CoV-2/Flu/RSV assay. Cepheid expects Xpert Xpress SARS-CoV-2/Flu/RSV to be available in advance of the 2020-2021 Northern Hemisphere respiratory season. 

Is the method already deployed in a UK hospital or clinical setting?

Cepheid has more than 25,000 GeneXpert Systems placed worldwide, with over 150 in active use throughout NHS hospitals and laboratories.  

The same GeneXpert System can be run 24/7 in healthcare settings of all sizes - including high throughput laboratories, near patient settings or those with limited onsite pathology services - enabling standardised, prompt access to diagnostics.

Example GeneXpert System settings in the UK include: Microbiology Laboratories, Blood Science Laboratories, EDs, A&Es, Paediatric Wards, Oncology Wards, Acute Medical Units, Pharmacies, Sexual Health Clinics, Prisons, Mobile Van Testing, and more.

Where is the kit manufactured?

USA and Sweden.

What is the turn around time (sample-to-result) for this method?

Approximately 45 minutes.

How will your solution communicate directly with the Laboratory Information Management System (LIMS)?

The GeneXpert System can communicate with the LIMS via a bi-directional interface.

How quickly could this be deployed and what are the dependencies?

GeneXpert Systems are available and actively used across the NHS. GeneXpert technology enables the rapid deployment of customisable, on-demand systems for a range of infectious diseases.

What is the likely production volume?

What are the risks and barriers to using this at scale?

The same GeneXpert System can be run 24/7 in healthcare settings of all sizes - including high throughput laboratories, near patient settings or those with limited onsite pathology services - enabling standardised, prompt access to diagnostics. GeneXpert Systems can be configured with a varying number of modules, or test bays, to meet the volume requirements of any setting. Smaller GeneXpert Systems are configured with 2 or 4 modules – meaning up to four different tests can be run at one time. Our largest GeneXpert System is configured with up to 80 modules – meaning as many as 80 tests can operate independently at any given time with a capacity of about 2,000 tests per day.

Who are you already partnering with on this?

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JulieDavies Sep 20, 2020

Great news - when will this be available and will kits be restricted?

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