NEW YORK – LumiraDx said Monday that it had nabbed US Food and Drug Administration Emergency Use Authorization and UK Health Security Agency Coronavirus Test Approvals process validation for LumiraDx's laboratory-based multiplex test for COVID-19 and influenza A and B.
The assay, dubbed LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete, uses the London-based firm's qSTAR single-step nucleic acid extraction and amplification methods on open RT-PCR instruments to detect and differentiate flu and SARS-CoV-2 infections within 20 minutes.
LumiraDx launched sales of the assay in June 2022 in the European Union and other markets that accept the CE-IVD marking. The recent regulatory decisions will allow commercialization in the US and UK.
Sanjay Malkani, president of LumiraDx's molecular diagnostics business, said in a statement that the high-throughput, highly sensitive test will give clinical diagnostic laboratories and reference laboratories fast and accurate results from a single sample.