LumiraDx SARS-CoV-2 Antigen Test Granted FDA Emergency Use Authorization

LumiraDx (London, UK) has secured Emergency Use Authorization from the US Food and Drug Administration (FDA) for its LumiraDx SARS-CoV-2 antigen test, which will help meet the global challenge of delivering fast and cost-efficient COVID-19 tests in community care settings.

The test detects antigen nucleocapsid protein from a nasal swab with results in under 12 minutes from sample application in symptomatic patients. In clinical studies, the LumiraDx SARS-CoV-2 antigen test demonstrated 97.6% positive agreement versus PCR in patients tested within 12 days of the onset of symptoms, making it the fastest, most sensitive antigen point of care test currently commercially available.

LumiraDx recently also received an EUA for its molecular lab reagent kit LumiraDx SARS-CoV-2 RNA STAR, a Fast Lab Solution that utilizes LumiraDx's innovative qSTAR amplification technology in an accessible high-throughput format with open molecular systems to improve efficiency and speed. LumiraDx SARS-CoV-2 RNA STAR reduces the amplification step of the PCR process from approximately one hour down to 12 minutes.

The company plans to begin shipping COVID-19 antigen tests by the end of the month, expects to produce two million tests in September, and will ramp to 10 million tests produced in December. In addition to the antigen test, the LumiraDx SARS-CoV-2 antibody test, for use with the LumiraDx Instrument, will shortly be submitted to the FDA for EUA review.

"Actionable diagnostic results at the point of care lead to better health outcomes," said Ron Zwanziger, LumiraDx CEO. "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."

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