LumiraDx’s FDA EUA Authorized SARS-CoV-2 Antigen Test Expanded to Include Screening of Asymptomatic Individuals

LumiraDx (London, UK) has announced that the intended use for its Food and Drug Administration (FDA) Emergency Use Authorization (EUA) authorized SARS-CoV-2 Antigen Test has been expanded to include screening of asymptomatic individuals.

This claim builds on its existing claim that covers use of the test in individuals suspected of COVID-19 by their healthcare provider within 12 days of symptom onset. The LumiraDx SARS-CoV-2 Antigen Test initially received EUA from the FDA in August of 2020 after demonstrating a 97.6% positive agreement and 96.6% negative agreement with RT-PCR in symptomatic patients. Asymptomatic individuals are defined as those without symptoms or other epidemiological reasons to suspect COVID-19.

The FDA authorized the expansion of the EUA for LumiraDx after reviewing company data on the performance of its SARS-CoV-2 Antigen Test in individual asymptomatic subjects collected between June 2020 and March 2021. Results indicated high sensitivity and specificity in asymptomatic individuals with the LumiraDx SARS-CoV-2 Ag Test, demonstrating an 82.1% positive agreement and 100% negative agreement with RT-PCR test in 222 subjects. These results illustrate high sensitivity offered by a microfluidic test compared to lateral flow SARS-CoV-2 antigen tests, which independent studies have shown to have sensitivities of less than 50% in asymptomatic populations.

“We understand that one of the most important challenges in keeping infection rates low is to be able to quickly and accurately identify SARS-CoV-2 infection in asymptomatic individuals,” said Nigel Lindner, PhD, LumiraDx Chief Innovation Officer. “Widespread testing in both symptomatic and asymptomatic individuals is a critical tool in preventing transmission of COVID-19. With this FDA authorization we can enable rapid, high sensitivity mass screening programs with our partners across schools, events, workplaces, clinics, travel and other settings and have the testing manufacturing capacity to support these new nation-wide testing mandates.”

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