LumiraDx announced that its rapid, nucleic acid amplification technology for high sensitivity, high throughput COVID-19 testing was reissued via Food and Drug Administration (FDA) Emergency Use Authorization (EUA).
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 provided within 20 minutes.
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 inclusivity of the detection of the novel SARS-CoV-2 Omicron variant.
The access to open RT-PCR 384-well systems provides laboratories an economical and scalable pathway to rapidly support increase in testing capacity and allow for same day result reporting.
The LumiraDx SARS-CoV-2 RNA STAR Complete has not been FDA cleared or approved, but has been authorized by FDA for emergency use under an EUA for use by authorized laboratories. The LumiraDX SARS-CoV-2 RNA STAR Complete has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
In clinical studies, the performance of LumiraDx RNA STAR Complete with asymptomatic individuals had a 95.2% positive agreement and 100% negative agreement when compared to another high sensitivity RT-PCR assay.
“Whether centralized or on the go, with new innovations such as high complexity mobile labs capable of performing 2000 molecular tests per hour with only two operators, we credibly demonstrate the innovation of the qSTAR technology with equivalent analytical performance to the legacy nucleic acid amplification technologies,” says Sanjay Malkani, president, LumiraDx Fast Lab Solutions stated. “With this revised EUA, allowing asymptomatic screening, pooling and use in 384-well RT-PCR systems, we enable laboratories to substantially increase the accessibility and affordability of COVID-19 molecular screening in community testing programs. With our growing Fast Lab Network, we have the potential to rapidly change the pace and possibilities of molecular testing.”
The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19.
For more information visit LumiraDx.
Featured image: The LumiraDX SARS-CoV-2 RNA STAR Complete has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Photo: LumiraDX