PerkinElmer's new coronavirus RT-PCR test gains FDA emergency-use authorisation

PerkinElmer announced that its new coronavirus RT-PCR test was awarded FDA emergency-use authorisation (EUA) to detect SARS-CoV-2. CEO Prahlad Singh remarked that "despite the challenging environment, our employees have demonstrated unwavering commitment over the past two months to combat this global pandemic." The company noted that its RT-PCR test is marketed as an in vitro diagnostic and is available in over 30 countries.

The news comes as antibody-based coronavirus tests are also now emerging to detect the infection. Earlier this week, Aytu BioScience announced that it received confirmation from the FDA allowing the company to distribute its COVID-19 IgG/IgM assay, which it says delivers results between two and 10 minutes at the point-of-care.

Separately, Emerald Organic Products and Todos Medical have announced the creation of their Corona Diagnostics joint venture to address demand for COVID-19 testing in the US. Todos will be responsible for securing FDA approval for the Colloidal Gold COVID-19 point-of-care screening test kit currently produced in China. The test uses a drop of blood from a finger prick to determine whether an individual has produced antibodies in response to COVID-19. It can generate results in two to 15 minutes and has already been CE-marked in Europe.

In addition, Corona Diagnostics said it is also bringing to market an automated PCR-based testing solution to use in combination with Colloidal Gold as it seeks to "establish a new standard of care for COVID-19 testing in the US."

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

PerkinElmer

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

Awaiting EUA, CE marked and 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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