BGI's real-time SARS-CoV-2 test gains FDA emergency-use authorisation

BGI Genomics announced Friday that its RT-PCR kit for detecting SARS-CoV-2 has been authorised by the FDA for emergency use, making it the company's first FDA-approved medical device. CEO Ye Yin noted that "as one of the first responders to the outbreak in China, we quickly scaled up our production and have deployed large numbers of kits for testing in China and globally in countries where our test kit has been approved."

BGI's nucleic acid detection kit for the virus was approved for use in China in January, and gained the CE mark earlier this month. More recently, the test was made commercially available for clinical use in the US.

The test, which is intended for the qualitative detection of SARS-CoV-2 in bronchoalveolar lavage fluid and throat swabs, can return results within three hours. BGI said it has manufacturing capacity for 600,000 reactions daily. The company noted that it is "actively scaling up to meet rapidly growing global demand," and is distributing its SARS-CoV-2 detection kits to more than 70 countries.

Separately on Friday, Sysmex announced that its 2019-nCoV fluorescence detection real-time RT-PCR kit gained approval for use in Japan.

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

Company

Test

Status

Sysmex

2019-nCoV Fluorescence Detection Real-Time RT-PCR Kit

Approved in Japan

Avellino

AvellinoCoV2 test

FDA EAU

Perkin Elmer

PerkinElmer New Coronavirus Nucleic Acid Detection Kit

FDA EUA

Mesa Biotech

Accula SARS-CoV-2 test

FDA EAU

BioFire Defense (bioMerieux)

BioFire COVID-19 test

FDA EAU

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

FDA EUA

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

CE marked, FDA EUA

BGI Genomics

RT-PCR test

CE markedFDA EUA, used in China

GenMark

ePlex SARS_CoV-2 test

FDA EUA

Cepheid

Xpert Xpress SARS-CoV-2

FDA EUA

Aytu Biosciences

COVID-19 IgG/IgM Rapid Test

Awaiting FDA approval; CE marked

20/20 BioResponse

CoronaCheck COVID-19 Rapid Antibody Test Kit

Awaiting FDA approval

Corona Diagnostics

Colloidal Gold COVID-19 POC screening test kit

CE marked

Solgent

DiaPlexQ Novel Coronavirus (2019-nCoV) Detection assay

CE marked/EUA in Korea, Philippines

Veredus Labs

VereCoV MDx

Singapore HSA provisional authorisation

CoSara Diagnostics

RT-PCR COVID-19 test

India CDSCO authorisation

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