LumiraDx Obtains CE Mark for Its High Sensitivity, High Throughput COVID-19 Molecular Test, RNA STAR Complete


This innovative molecular assay uses proprietary qSTAR (Qualitative Selective Temperature Amplification Reaction) technology, which forms the basis of LumiraDx’s point-of-care molecular testing. In 2020, the technology was used to launch Fast Lab Solutions, a dedicated business unit to help address the COVID-19 testing crisis by increasing existing lab testing capacity. LumiraDx RNA STAR Complete SARS-CoV-2 uses a direct amplification method that combines lysis and amplification in one step, detecting SARS-CoV-2 viral nucleic acid in less than 20 minutes or less on systems Common open channel PCR – a process that takes over an hour.

“With the CE marking, we are delighted to be able to now offer our tests through Europe and provide rapid and accurate testing to support laboratory testing programs, ”said Sanjay Malkani President, LumiraDx Fast Lab Solutions. He continued, “Our innovative qSTAR technology simplifies and accelerates the capability of COVID-19 molecular testing without including high detection sensitivity. Additionally, with the small footprint associated with our technology, we are able to bring this test out of the lab and into the mobile. units to deliver accurate and reliable results in environments where fast turnaround times are critical. “

LumiraDx’s FastLab team of scientists regularly monitor post-market reports to confirm in silico analyzes the detection by qSTAR technology 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 offset, providing confidence and accuracy in the detection of SARS-CoV-2 and all variants of interest and known variants of concern, including Delta and Delta Plus variants of SARS-CoV-2. *

RNA STAR Complete SARS-CoV-2 is already in use in the United States in laboratories and mobile units to support testing in environments requiring fast and accurate results. In Europe, LumiraDx is teaming up to make testing available in similar environments, including the workplace and schools, where early diagnosis can help quickly identify hot spots and avoid future blockages.

About LumiraDx RNA STAR Complete SARS-CoV-2

RNA STAR Complete SARS-CoV-2 received EUA from the FDA on October 14, 2020 with a reissued EUA in March 2021 to provide an improvement in the detection limit of 1.8 copies / µl and additional PCR system validations to allow laboratories to expand their testing capabilities.

LumiraDx has completed the process of declaring compliance with the essential requirements of the In Vitro Diagnostic Directive (IVDD 98/79 / EC) and CE marked its RNA STAR Complete SARS-CoV-2 test. The test is now available for sale in the European Economic Area.

About LumiraDx FastLab solutions

LumiraDx FastLab solutions, based on San Diego, California, is a dedicated LumiraDx business unit that supports high complexity laboratory testing using its innovative qSTAR nucleic acid amplification technology in a high throughput accessible format to take advantage of current molecular laboratory operations. Using FastLab Solutions enables laboratories to improve their efficiency and reduce the time to results.

About LumiraDx

LumiraDx was founded in 2014 by a group of entrepreneurs: Ron Zwanziger, our CEO; Dave scott, Ph.D., our CTO; and Jerry McAleer, Ph.D., our Chief Scientist, with a proven track record of building and scaling diagnostic companies over three decades, including companies such as Medisense, Inc., Inverness Medical Technology Inc . and Alere Inc. The company raised approximately $ 1 billion through debt and equity from institutional and strategic investors, including the Bill & Melinda Gates Foundation, Morningside Ventures, US Boston Capital Corporation and Petrichor Healthcare Capital Management. Based in the UK, with primary R&D and manufacturing activities in Stirling, Scotland and San diego, california, in the United States, and supported by its global subsidiaries to provide access to all major markets, LumiraDx has more than 1,200 employees worldwide.

More information on LumiraDx and our SARS-CoV-2 product offerings can be found at lumiradx.com

* Although validated internally by FastLab, the LumiraDX RNA STAR Complete SARS-CoV-2 Test Kit has not been approved, approved or cleared by the FDA under the EUA for the detection of a variant of SARS -CoV-2.

Copyright © 2021 LumiraDx and its affiliates. LumiraDx and qSTAR are trademarks of LumiraDx International LTD. All other trademarks are the property of their respective owners.

Photo – https://mma.prnewswire.com/media/1555495/RNA_STAR_Complete_box.jpg

SOURCE LumiraDx Limited


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