LumiraDx Achieves CE Mark for Its High Sensitivity, High Throughput COVID-19 Molecular Test, RNA STAR Complete
As part of LumiraDx’s Fast Lab Solutions, the test enables laboratories to increase throughput of their existing open channel PCR systems to more than 250 tests per hour
London, UK- June 30, 2021 – LumiraDx announced today that it has achieved CE Marking for LumiraDx RNA STAR Complete SARS-CoV-2. The test, which was initially granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) in October of 2020 and re-issued in March 2021, is 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 RNA STAR Complete SARS-CoV-2 enables laboratories to quickly adopt and support their testing programs in and outside the laboratory such as mobile lab units that provide easy access to testing wherever it is needed.
This innovative molecular test uses proprietary qSTAR (qualitative Selective Temperature Amplification Reaction) 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 testing capacity. LumiraDx RNA STAR Complete SARS-CoV-2 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 or less on common open channel PCR systems – a process that typically takes more than one hour.
"With CE Mark, we are thrilled to now be able to offer our testing across Europe and provide fast and accurate testing to support laboratory testing programs,” stated Sanjay Malkani President, LumiraDx Fast Lab Solutions. He continued, “Our innovative qSTAR technology simplifies and accelerates COVID-19 molecular testing capacity without comprising high sensitivity of detection. In addition, with the small footprint associated with our technology, we are able to bring this testing outside of the laboratory and into mobile units to deliver accurate and trusted results in environments where quick turnaround times are crucial.”
LumiraDx’s FastLab team of scientists regularly monitors post-market reports to confirm in silico analysis qSTAR technology’s detection of all known variants currently in circulation. To date, the FastLab team has aligned 1,750,156 sequences with 99.5% showing perfect identity or a single mismatch, providing confidence and accuracy in the detection of SARS-CoV-2 and all known Variants of Interest and Variants of Concern, including the Delta and Delta Plus SARS-CoV-2 variants.*
RNA STAR Complete SARS-CoV-2 is already being used across the US in labs and mobile units to support testing in environments that require fast and accurate results. In Europe, LumiraDx is partnering to make testing available in similar settings including the workplace, and schools where early diagnosis can help to quickly identify hotspots and avoid future lockdowns.
About LumiraDx RNA STAR Complete SARS-CoV-2
RNA STAR Complete SARS-CoV-2 received an EUA from the FDA on October 14, 2020 with a re-issued EUA in March 2021 to provide improvement in the limit of detection of 1.8 copies/µl and additional PCR system validations to allow labs to expand their testing capabilities.
LumiraDx has completed the process for declaring conformity to the essential requirements of the In Vitro Diagnostics Directive (IVDD 98/79/EC) and has CE Marked its RNA STAR Complete SARS-CoV-2 assay. The test is now available for sale in the European Economic Area.
About LumiraDx FastLab Solutions
LumiraDx FastLab Solutions, based in San Diego California, 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, CA, U.S., and supported by its worldwide affiliates to provide access in all major markets, LumiraDx has over 1200 employees worldwide.
Further information on LumiraDx and our SARS-CoV-2 product offerings visit available at lumiradx.com
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*While internally validated by FastLab, LumiraDX RNA STAR Complete SARS-CoV-2 assay kit has not been FDA cleared, approved, or authorized by FDA under EUA for the detection of any SARS-CoV-2 variant.
Copyright© 2021 LumiraDx and affiliates. LumiraDx and qSTAR are trademarks of LumiraDx International LTD. All other trademarks are the property of their respective owners