LumiraDx Receives Reissued FDA Emergency Use Authorization for Its High Sensitivity, Rapid COVID-19 Molecular Lab Test
LumiraDx SARS-CoV-2 RNA STAR Complete, part of LumiraDx’s Fast Lab Solutions, will allow laboratories to increase throughput of their existing open channel PCR systems to more than 250 tests per hour.
London, UK – April 13, 2021 – LumiraDx announced today 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. “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.”
About LumiraDx SARS-CoV-2 RNA STAR Complete
SARS-CoV-2 RNA STAR Complete received an EUA from the FDA on October 14, 2020 and LumiraDx plans to complete the process to obtain CE Mark. The re-issued EUA comprised of improved limit of detection and additional PCR system validations.
Key product specifications include:
- Limit of Detection – 1.8 copy/µL
- Direct Amplification – 20 minutes or less after sample processing
- Authorized for use on the following PCR systems – Roche LightCycler® 480 Instrument II, Applied Biosystems® 7500 Fast Dx Real-Time PCR Instrument, Applied Biosystems QuantStudioTM 5 Real-Time PCR System, Applied Biosystems QuantStudioTM 7 Flex Real-Time PCR System, Applied Biosystems QuantStudioTM 7 Pro Real-Time PCR System, Bio-Rad CFX96 TouchTM System, Agilent AriaMx Real-Time PCR System, or the Agilent Stratagene Mx3005P Real-Time PCR System.
EUA Status of LumiraDx SARS-CoV-2 RNA STAR Complete
The LumiraDx SARS-CoV-2 RNA STAR Complete has not been cleared or approved by the FDA. The LumiraDx SARS-CoV-2 RNA STAR Complete has been authorized by FDA under an EUA only for the detection of nucleic acid from SARS-CoV-2. The test has not been authorized for use to detect any other viruses or pathogens. The tests are authorized in the United States 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 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
About LumiraDx FastLab Solutions
LumiraDx Fast Lab Solutions is a dedicated LumiraDx business unit that 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 FastLab Solutions enables laboratories to improve efficiency and reduce time to result.
LumiraDx was founded in 2014 by a group of entrepreneurs: Ron Zwanziger, our Chairman and Chief Executive Officer; Dave Scott, Ph.D., our Chief Technology Officer; and Jerry McAleer, Ph.D., our Chief Scientist, who have a successful track record in building and scaling diagnostics businesses over three decades, including at companies such as Medisense, Inc., Inverness Medical Technology Inc. and Alere Inc. The company has raised approximately $1 Billion through debt and equity from institutional and strategic investors including the Bill & Melinda Gates Foundation, Morningside Ventures, U.S. Boston Capital Corporation and Petrichor Healthcare Capital Management. Based in the UK, with primary R&D and manufacturing operations in Stirling, Scotland and San Diego, U.S., and supported by its worldwide affiliates to provide access in all major markets, LumiraDx has over 1200 employees worldwide.
LumiraDx develops, manufactures, and commercializes an innovative point of care diagnostic Platform. The LumiraDx Platform is designed to deliver lab comparable diagnostic results at the point of care in minutes. It is designed to be affordable and accessible for healthcare providers globally, and to strengthen community-based healthcare.
Further information on LumiraDx and our SARS-CoV-2 product offerings visit available at lumiradx.com
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