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LumiraDx Gets CE Marks for SARS-CoV-2 Test, COVID-19-Flu Assay

NEW YORK — LumiraDx said on Wednesday that it has received CE marking for a molecular SARS-CoV-2 test and an assay that tests for both SARS-CoV-2 and influenza virus.

The Dual-Target SARS-CoV-2 STAR Complete test detects two gene markers to identify the presence of SARS-CoV-2, according to the company. The LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay allows for the simultaneous detection and differentiation of influenza A, influenza B, and SARS-CoV-2.

Both tests use LumiraDx's qSTAR single-step nucleic acid extraction and amplification technology and run on open RT-PCR instruments. Results are provided within 20 minutes.

Last month, London-based LumiraDx reported an 18 percent increase in first quarter revenues on strong sales of its COVID-19 testing products.