LumiraDx and Rapid COVID-19 Molecular Lab Test

LumiraDx announced that it has received a reissued Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for LumiraDx SARS-CoV-2 RNA STAR Complete, a rapid, nucleic acid amplification method for high sensitivity, high throughput COVID-19 testing.

With improved performance claims and access to additional open channel PCR systems, LumiraDx SARS-CoV-2 RNA STAR Complete enables laboratories to leverage their existing PCR systems to serve mass testing applications such as schools, workplace, travel, and events.

LumiraDx SARS-Cov-2 RNA STAR Complete uses proprietary qSTAR technology, which forms the basis of LumiraDx’s point of care molecular assays. In 2020, the technology was used to launch Fast Lab Solutions a dedicated business unit to help address the COVID-19 testing crisis by expanding existing laboratory capacity. LumiraDx SARS-Cov-2 RNA STAR Complete utilizes a direct amplification method that combines lysis and amplification in a single step, detecting SARS-CoV-2 viral nucleic acid in under 20 minutes on common open channel PCR systems – a process which typically takes more than one hour.

“LumiraDx’s innovative qSTAR technology simplifies and accelerates COVID-19 molecular lab testing capacity while maintaining high sensitivity of detection,” said Pooja Pathak, VP Platform Strategy.

Based on: Lumiradx

#News #Health #Medical #LumiraDx #Whealthnews