FDA issues first emergency use authorisation for a point-of-care COVID-19 diagnostic to Cepheid's Xpert Xpress SARS-CoV-2 

Cepheid announced that it has received FDA emergency use authorisation for Xpert Xpress SARS-CoV-2, a rapid molecular diagnostic test for qualitative detection of SARS-CoV-2, representing the first point-of-care COVID-19 diagnostic test to receive this designation. The company said that it intends to launch the test, which runs on the company’s GeneXpert systems, providing results in around 45 minutes, by March 30.

Warren Kocmond, president of Cepheid, which was acquired by Danaher in 2016, remarked that "Cepheid currently has nearly 5000 GeneXpert systems in the US capable of point-of-care testing and for use in hospitals." He added that "our automated systems do not require users to have specialty training to perform testing — they are capable of running 24/7, with many systems already doing so today."

David Persing, chief medical and technology officer, noted that "by leveraging the design principles of our current Xpert Xpress Flu/RSV cartridge technology, in which multiple regions of the viral genome are targeted to provide rapid detection of current and potential future variants of SARS-CoV-2, we have developed a test that provides reference lab-quality results in multiple settings where actionable treatment information is needed quickly." The Xpert Xpress Flu/RSV test gained FDA clearance in 2017 for the diagnosis of influenza and respiratory syncytial virus infection.

Meanwhile, Health and Human Services Secretary Alex Azar, remarked that "the test we’re authorising today will be able to provide Americans with results within hours, rather than days like the existing tests…With new tools like point-of-care diagnostics, we are moving into a new phase of testing, where tests will be much more easily accessible to Americans who need them."

Here is a non-exhaustive list of the status of some COVID-19 tests:

Abbott

RealTime SARS-CoV-2 assay

 

FDA EUA

Quest Diagnostics

Quest SARS-CoV-2 rRT-PCR

 

FDA EUA

Quidel

Lyra SARS-CoV-2 Assay

 

FDA EUA

LabCorp

COVID-19 T-PCR test

 

FDA EUA

Hologic

Panther Fusion SARS-COV-2 Assay

 

FDA EUA

Centers for Disease Control and Prevention

2019-nCoV RT-PCR Diagnostic Panel

 

FDA EUA

Wadsworth Center, NYSDOH

New York SARS-CoV-2 RT-PCR Diagnostic Panel

 

FDA EUA

Roche

cobas SARS-CoV-2

 

FDA EUA

Thermo Fisher

TaqPath COVID-19 Combo Kit

 

FDA EUA

BD/BioGX

BD MAX COVID-19 Test

 

FDA EUA

Co Diagnostics

Logix Smart COVID-19 test

 

Awaiting EUA; CE marked

Fulgent/MedScan

COVID-19 NGS Test

 

Awaiting EUA

Diatherix Eurofins

COVID-19 Panel

 

Awaiting EUA

Stanford Medicine

COVID-19 RT-PCR test

 

In-house LDT

UC San Diego Health System

COVID-19 Test

 

In-house LDT

Diasorin

Simplexa COVID-19 Direct Assay

 

In development

Opko Health

COVID-19 test

 

In development

Qiagen

QIAstat-Dx Respiratory 2019-nCoV Panel

 

CE marked

CerTest Biotec

Viasure COVID-19 test

 

CE marked

Genomica

CLART COVID-19 test

 

CE marked

Novacyt

COVID-19 test

 

CEmarked/RUO

BGI Genomics

RT-PCR test

 

Awaiting EUA, CE marked and used in China

GenMark

ePlex SARS_CoV-2 test 

FDA EUA

Cepheid

Xpert Xpress SARS-CoV-2

FDA EUA

 

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