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Ortho Clinical Diagnostics COVID-19 Antigen Test Receives FDA EUA for High-Volume Testing

NEW YORK – Ortho Clinical Diagnostics announced on Tuesday that the US Food and Drug Administration has issued Emergency Use Authorization for the company's Vitros SARS-CoV-2 Antigen test for detection of the coronavirus.

According to the Raritan, New Jersey-based firm, the test is the first high-volume COVID-19 antigen test to receive EUA. It previously was CE marked in November.

Ortho said the test can be used for mass testing of SARS-CoV-2 and runs on the firm's high-volume Vitros systems, which are installed in more than 5,600 laboratories worldwide, including 1,500 labs in the US. Specifically, the test runs on the Vitros 3600 Immunodiagnostic system and the Vitros 5600/XT 7600 Integrated systems, according to a document filed with the FDA.

The Vitros platforms can run up to 130 of the Vitros SARS-CoV-2 Antigen test per hour, Ortho said.

The FDA said that the test is for the qualitative detection of SARS-CoV-2 nucleocapsid protein antigens in nasopharyngeal swab specimens collected in the US Centers for Disease Control and Prevention's formulation of viral transport media (VTM), Copan Universal Transport Media, Remel M4RT VTM, or Hard R99 VTM.

"As the pandemic continues to devastate our communities and economy, laboratory professionals have been working under extraordinary circumstances to deliver critical COVID-19 testing data to patients, clinicians, and communities," Ortho Chairman and CEO Chris Smith said in a statement. "Even as vaccine inoculation programs roll out, mass-scale testing remains an essential tool in fighting COVID-19. Ortho's accurate, high-volume COVID-19 antigen test can play a pivotal role in the global response to this virus." 

The company, which recently filed with the US Securities and Exchange Commission to go public, noted a recent study from the Rockefeller Foundation that estimated about 200 million COVID-19 tests per month would be necessary to open the economy safely.

Ortho said that it currently can deliver 5 million tests per month and will be able to increase that figure to 15 million tests per month in February.