LumiraDx announced today that it received FDA emergency use authorization (EUA) for its LumiraDX SARS-CoV-2 point-of-care antigen test.
London-based LumiraDx’s test is designed to detect antigen nucleocapsid protein from a nasal swab and provide results in less than 12 minutes from sample application in symptomatic patients, according to a news release.
In clinical studies, the LumiraDx SARS-CoV-2 antigen test demonstrated 97.6% positive agreement compared to PCR in patients tested within 12 days of the onset of symptoms, making it what the company touts as the fastest, most sensitive antigen point-of-care test commercially available at this time.
LumiraDx intends to begin shipping its COVID-19 antigen tests by the end of August with a plan in place to produce 2 million tests in September before ramping up to 10 million in December.
“Actionable diagnostic results at the point of care lead to better health outcomes,” LumiraDx CEO Ron Zwanziger said 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.”