FDA grants emergency approval for new COVID-19 antigen test

August 21, 2020

The new test was developed by LumiraDx.

The U.S. Food and Drug Administration (FDA) has approved an emergency use authorization (EUA) for a new point of care COVID-19 antigen test developed by LumiraDx.

The LumiraDx SARS-CoV-2 antigen test detects antigen nucleocapsid protein from a nasal swab with results coming in less than 12 minutes from sample application in symptomatic patients. In studies the new test demonstrated 97.6 percent positive agreement versus PCR in patients tested within 12 days of the onset of symptoms, making it the fastest and most sensitive antigen point of care test on the market, according to a news release.

"Actionable diagnostic results at the point of care lead to better health outcomes," Ron Zwanziger, LumiraDx CEO, says in the release. "Now that the FDA EUA has been received, we are working with health systems, major retail clinics, and employers to get our Platform to healthcare providers quickly to utilize in their testing programs."

LumiraDx plans to begin shipping these tests by the end of the month and expects to produce 2 million tests in September and 10 million tests in December, the release says.

The company also recently received an EUA for a molecular lab reagent kit, which is a Fast Lab Solution that utilizes LumiraDx’s qSTAR amplification technology which reduces the amplification step of the PCR process from one hour to about 12 minutes, according to the release.

The company is also looking to seek and EUA for their antigen test, the LumiraDx SARS-CoV-2 antibody test, the release says.