LumiraDx Rapid COVID-19 Test Authorized for Emergency Use

The FDA has granted an Emergency Use Authorization (EUA) for LumiraDx’s rapid SARS-CoV-2 assay.

The EUA limits the assay’s use to certified laboratories that use the Massachusetts company’s LumiraDx testing platform. The test uses nasal swabs from suspected COVID-19 patients within the first 12 days of symptom onset to detect the presence of viral antigens.

The company said it plans to produce 2 million tests in September, increasing to 10 million tests in December.