London-based LumiraDx has received a reissued emergency use authorization (EUA) from the 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,” says Pooja Pathak, VP Platform Strategy. “With the new product improvements, RNA Star Complete reagents provide high sensitivity test results with almost all open channel PCR systems in the US and enable a throughput in one hour what fully automated systems deliver in a day. With the EUA authorization, we are working with our commercial partners to implement fast, accurate testing at events, schools and workplaces, in support of safe and effective reopening of society.”
For more information, visit LumiraDx.
Featured image: LumiraDx SARS-Cov-2 RNA Star Complete box (Courtesy: LumiraDx)