LumiraDx CE Marked COVID/Influenza Molecular Tests to Expand Global Testing Capabilities

LumiraDx (London, UK) has achieved CE Mark for two new Fast Lab Solutions molecular tests, including Dual-Target SARS-CoV-2 STAR Complete and SARS-CoV-2 & Flu A/B RNA STAR Complete. These high-sensitivity and high-throughput tests help to expand testing capabilities across the globe.

LumiraDx's continued innovation of its qSTAR technology, which utilizes a single-step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments, has led to the development of multiplexing capabilities. LumiraDx Fast Lab Solutions supports high-complexity laboratory testing by utilizing its innovative qSTAR nucleic acid amplification technology in an accessible high-throughput format to leverage current molecular laboratory operations. Utilizing Fast Lab Solutions enables laboratories to improve efficiency and reduce time to result.

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. SARS-CoV-2 & Flu A/B RNA STAR Complete compares to high sensitivity RT-PCR with a positive percent agreement (PPA) of 94.1% for SARS-CoV-2, and 92.3% for influenza A, and 95.7% for influenza B and a negative percent agreement (NPA) of >99.5% in symptomatic individuals.

The Dual-Target SARS-CoV-2 STAR Complete multiplex assay simultaneously detects two gene markers to identify the presence of SARS-CoV-2, which will meet certain regulatory requirements in numerous regions that need two or more targets for a COVID-19 diagnostic. Compared to a high sensitivity RT-PCR, Dual-Target SARS-CoV-2 STAR Complete proved to have a PPA of 97.7% for SARS-CoV-2 and a NPA of 100% in symptomatic individuals.

"As the pandemic persists, we remain focused on bringing to market high-quality molecular diagnostics that further remove testing barriers and enhance laboratory operations," explained Sanjay Malkani, President of LumiraDx Fast Lab Solutions. He continued, "We are pleased to demonstrate unrivaled innovation with direct method, high-throughput, highly sensitive assays for open molecular platforms - with results available in 20 minutes - and the added benefit of accurately detecting influenza and COVID-19 from a single sample."

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