LumiraDx Limited announced that it has received an Emergency Use Authorization from the U.S. Food and Drug Administration and validation for use by the UKHSA under the CTDA process for the LumiraDx SARS-CoV-2 & Flu A/B STAR Complete assay that will allow high complexity laboratories to quickly identify and differentiate individuals suspected by a healthcare provider of respiratory viral infection consistent with COVID. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. This makes it essential to correctly identify them in order to treat and manage patients accordingly.

The LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete multiplex test allows for the simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2 infections within 20 minutes or less. The assay takes advantage of the innovative qSTAR technology which utilizes a single-step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments which will be a powerful diagnostic tool for this respiratory season. LumiraDx launched the LumiraDx SARS-CoV-2 & Flu A/B STAR Complete assay in the European Union and other markets that accept CE-IVD in June 2022 and will now begin commercialization of the test in the U.S. and U.K.