Emergency Use Authorizations Increase for COVID-19 Tests

Three more COVID-19 tests received emergency use authorization (EUA) from the FDA, this week.¹

EUAs were issued to BioFire Defense and Mesa Biotech on Monday and Perkin Elmer on Tuesday.¹

EUA is not an approval from the FDA, nor are these tests intended for any other pathogens or viruses. The EUA designation allows the test to be used to detect SARS-CoV-2, the virus that causes COVID-19, for the duration of the continuing pandemic.¹

The FDA has given EUA to 16 COVID-19 tests, to date, including the 3 most recent.¹

BioFire Defense²

The BioFire COVID-19 test has been validated by the French Reference Center for respiratory infectious diseases.

This test detects SARS-CoV-2 in about 45 minutes from a nasopharyngeal swab in transport media, according to bioMérieux, the parent company of BioFire Defense.

This test runs on fully automated platforms and is designed to be extremely easy to use, therefore requiring minimal training and skills in molecular biology.

BioFire COVID-19 was developed with funding from the US Department of Defense (DoD) by leveraging an existing contract agreement with BioFire Defense.

This is the second of 3 tests being developed for diagnostic use as part of bioMérieux’s strategic response to the COVID-19 pandemic, according to the company.

BioMérieux is scaling up supplies of the BioFire COVID-19 test at multiple production facilities in Salt Lake City, Utah. The initial test kits are committed to the DoD for redistribution. However, test kits will become available for commercial distribution in the United States. BioMérieux expects to have maximum production capability within a few weeks.

Mesa Biotech³

The Accula SARS-CoV-2 Test is designed is to be affordable and yield results in 30 minutes, according to the company.

It is intended for point-of-care use, including long-term nursing facilities, physician office labs, temporary screening facilities, urgent care.

This test uses this patented technology for “near patient” testing allowing testing outside of the central laboratory, according to Mesa Biotech.

The product is a visually read test using polymerase chain reaction technology to detect SARS-CoV-2 through throat and nasal swab samples.

Mesa Biotech’s technology was developed at Los Alamos National Lab supported by National Institutes of Health grants from the National Institute of Allergy and Infectious Diseases and the Western Regional Centers for Excellence in Biodefense and Emerging Infectious Disease program. The company has also received funding from the US Health and Human Services for development of its test.

PerkinElmer⁴

Clinical laboratories certified under clinical laboratory improvement amendments (CLIA) can immediately begin using the SARS-CoV-2 Real-time RT (reverse transcription)-PCR Assay to detect the virus, according to the company.

PerkinElmer’s test is marketed as an in vitro diagnostic device by meeting the requirements of the European In Vitro Diagnostic Directive and is available in more than 30 countries worldwide.

References

• FDA. Emergency use authorizations. www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#coronavirus2019. Updated March 25, 2020. Accessed March 25, 2020.
• BioMérieux receives emergency use authorization for BIOFIRE® COVID-19 test [news release]. Marcy l’Étoile, France; March 24, 2020: bioMérieux. biomerieux.com/en/biomerieux-receives-emergency-use-authorization-biofirer-covid-19-test Accessed March 25, 2020.
• Mesa Biotech receives emergency use authorization from FDA for a 30 minute point of care molecular COVID-19 Test [news release]. San Diego, CA; March 24, 2020: Mesa Biotech website. mesabiotech.com/news/euacoronavirus. Accessed March 25, 2020.
• FDA provides emergency use authorization to PerkinElmer for COVID-19 testing [news release]. Waltham, MA: March 24, 2020: PerkinElmer website. ir.perkinelmer.com/news-releases/news-release-details/fda-provides-emergency-use-authorization-perkinelmer-covid-19?_ga=2.228712732.1003230773.1585164210-1788038692.1585164210 Accessed March 25, 2020.