First High-Volume COVID-19 Antigen Test Receives FDA Emergency Use Authorization

On Jan 13, 2021

Raritan-based Ortho Clinical Diagnostics, a global leader of in vitro diagnostics, announced that its VITROS® SARS-CoV-2 Antigen Test, designed to detect active infection, has become the first high-volume COVID-19 antigen test to receive U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA). U.S. distribution of the test commenced in November 2020 under an FDA Emergency Use Notification (EUN); the test was also granted CE Mark in November 2020.

Ortho’s antigen test comes at a critical time. A recent Rockefeller Foundation report estimates that the U.S. will need to increase coronavirus testing capacity by nearly 10-fold — from 21 million to 193 million tests per month — in order to reopen schools safely and protect nursing homes.

With utility for mass-scale testing and same-day results for labs, Ortho’s latest COVID-19 solution can run up to 130 tests per hour and immediately help hospitals and reference labs address testing backlogs, supply shortages, and delayed results.

“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,” said Chris Smith, chairman and chief executive officer, Ortho Clinical Diagnostics. “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.”

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