FDA Reissues Emergency Use Authorization For LumiraDx's COVID-19 Testing Solution

The FDA has reissued Emergency Use Authorization (EUA) to LumiraDx Ltd's LMDX SARS-CoV-2 RNA STAR Complete, a rapid nucleic acid amplification technology for high sensitivity, high throughput COVID-19 testing.

• The EUA now includes testing of asymptomatic individuals, pooling of up to five individuals, access to 384-well configuration on validated open RT-PCR systems, and detection of Omicron variant.
• LumiraDx SARS-CoV-2 RNA STAR Complete, developed with proprietary qSTAR technology, utilizes a single-step direct method for nucleic acid extraction and amplification on validated open RT-PCR instruments, with results within 20 minutes.
• In October, LumiraDx received approval for its COVID-19 antigen test for use in India.
• Price Action: LMDX shares are up 0.11% at $9.50 during the market session on the last check Wednesday.