LumiraDx Gets CE Mark for Two Multiplex Tests That Can Identify COVID-19

LumiraDx has been awarded a CE mark for two multiplex tests, its Dual-Target SARS-CoV-2 STAR Complete and LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assays. STAR stands for selective temperature amplification reaction.

The STAR technology uses a single-step method for nucleic acid extraction and amplification on real-time polymerase chain reaction (RT-PCR) equipment.

The Dual-Target SARS-CoV-2 STAR Complete assay simultaneously detects two gene markers to identify the presence of the SARS-CoV-2 virus, while the LumiraDx SARS-CoV-2 & Flu A/B RNA STAR assay differentiates between influenza A, influenza B and COVID-19 infections.

Results from the two assays are comparable to high-sensitivity RT-PCR tests, the company said.