LONDON, January 14, 2022 /PRNewswire/ — LumiraDx (Nasdaq: LMDX), a next-generation point-of-care diagnostics company, today announced that results from ongoing testing and monitoring of COVID-19 variants show that its SARS-CoV-2 antigen test detects Omicron variant. Internal wet testing with live Omicron virus demonstrated that the LumiraDx SARS-CoV-2 Antigen assay detects the Omicron variant with comparable sensitivity to other variants. In original U.S. Food and Drug Administration (“FDA”) Emergency Use Authorization (“EUA”) clinical studies, the test demonstrated 100% concordance with RT-PCR up to ‘at CT 33.0. These latest test results confirm the company’s previous announcement based on in silico and recombinant protein analysis of specific mutations of the Omicron variant that it was confident that the performance of its antigenic and molecular tests will not be affected by these mutations.
Nigel Lindner, PhD, Chief Innovation Officer at LumiraDx, commented, “Testing is an essential tool for controlling the spread of the virus and we are committed to conducting research that confirms the sensitivity of our tests as soon as new variants emerge. We continuously monitor COVID -19 variants and assess new ones as they emerge through our internal testing as well as through our collaborations with lab partners around the world Our test’s ability to detect Omicron and other variants of concern, combined with both CE Marking and FDA EUA along with the intended use which includes screening of asymptomatic people makes the LumiraDx SARS-CoV-2 Antigen test a valuable tool at this stage of the pandemic .
About the LumiraDx SARS-CoV-2 Antigen Test
The LumiraDx SARS-CoV-2 Antigen test has not been cleared or approved by the FDA, but has been cleared by the FDA under an EUA for use by approved laboratories. The product has been authorized only for the detection of SARS-CoV-2 proteins, and not for other viruses or pathogens. Emergency use of the product is authorized only for the duration of the declaration of the existence of circumstances justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID- 19 pursuant to Section 564(b)(1) of the Federal Federal Food, Drug, and Cosmetic Act, 21 USC § 360bbb-3(b)(1), unless the declaration is terminated or the authorization is revoked earlier.
LumiraDx (Nasdaq: LMDX) is a next-generation point-of-care diagnostics company transforming community healthcare. Founded in 2014, LumiraDx manufactures and markets an innovative diagnostic platform that supports a wide range of tests with comparable performance from the lab to the point-of-care. LumiraDx diagnostic testing solutions are deployed by governments and major healthcare facilities in laboratories, emergency care, medical offices, pharmacies, schools and workplaces to screen, diagnose and monitor the well -being as well as the disease. LumiraDx has more than 30 tests on the market and in development covering infectious diseases, cardiovascular diseases, diabetes and bleeding disorders, all on the LumiraDx platform. Additionally, LumiraDx has a comprehensive portfolio of fast, accurate, and cost-effective COVID-19 testing solutions from the lab to the point of need.
LumiraDx is based in the UK with over 1600 employees worldwide. More information about LumiraDx and the LumiraDx platform can be found at www.lumiradx.com
Caution Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995, including statements regarding the benefits of the LumiraDx SARS-CoV-2 Antigen test and its ability to detect variants and mutations of COVID -19. These statements involve risks, uncertainties and other factors that may cause actual results, levels of activity, performance or achievements to differ materially from the information expressed or implied by these forward-looking statements, including including, but not limited to, general economic, political and business factors. conditions; the effect of COVID-19 on LumiraDx’s business and financial results; maintaining EUA authorization for the LumiraDx SARS-CoV-2 antigen test (as reissued); and the factors discussed under the heading “Risk Factors” in the proxy statement and prospectus filed pursuant to Rule 424(b)(3) with the Securities and Exchange Commission (“SEC”) on September 3, 2021 and other filings with the SEC. Although LumiraDx believes it has a reasonable basis for each forward-looking statement contained in this press release, LumiraDx cautions you that such statements are based on a combination of facts and factors currently known to it and its projections for the future, about which she can’t be sure. LumiraDx undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
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