London, UK (January 14, 2022): 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 its SARS-CoV-2 Antigen test detects the Omicron Variant. In-house wet testing with live Omicron virus demonstrated that the LumiraDx SARS-CoV-2 Antigen test detects the Omicron variant with comparable sensitivity to other variants. In the original U.S. Food and Drug Administration (“FDA”) Emergency Use Authorization (“EUA”) clinical studies, the test demonstrated 100% agreement with RT-PCR up to Ct 33.0. These latest testing results confirm the company’s previous announcement based on in-silico and recombinant protein analysis of the specific mutations in the Omicron variant that it was confident that the performance of its antigen and molecular tests will not be impacted by these mutations.
Nigel Lindner, PhD, Chief Innovation Officer at LumiraDx commented, “Testing is a critical tool to control the spread of the virus and we have been committed to conducting research that confirms the sensitivity of our tests as soon as new variants emerge. We continuously monitor for COVID-19 variants and evaluate new ones as they appear through our in-house testing as well as through our collaborations with laboratory partners globally. The ability of our test to detect Omicron and other variants of concern, combined with both CE Marking and EUA from FDA with the intended use that includes the screening of asymptomatic individuals 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 FDA cleared or approved, but has been authorized by FDA under an EUA for use by authorized laboratories. The product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of the product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb- 3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
LumiraDx (Nasdaq: LMDX) is a next-generation point of care diagnostics company that is transforming community-based healthcare. Founded in 2014, LumiraDx manufactures and commercializes an innovative diagnostic Platform that supports a broad menu of tests with lab comparable performance at the point of care. LumiraDx diagnostic testing solutions are being deployed by governments and leading healthcare institutions across laboratories, urgent care, physician offices, pharmacies, schools, and workplaces to screen, diagnose, and monitor wellness as well as disease. LumiraDx has, on the market and in development, 30+ tests covering infectious diseases, cardiovascular diseases, diabetes, and coagulation disorders, all on the LumiraDx Platform. In addition, LumiraDx has a comprehensive portfolio of fast, accurate, and cost-efficient COVID-19 testing solutions from the lab to point of need.
LumiraDx is based in the UK with more than 1600 employees worldwide. Further information on LumiraDx and the LumiraDx Platform is available at www.lumiradx.com
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. 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 be materially different from the information expressed or implied by these forward-looking statements, including, among others, general economic, political and business 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 re-issued); and those factors discussed under the header “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 that it has a reasonable basis for each forward-looking statement contained in this press release, LumiraDx cautions you that these statements are based on a combination of facts and factors currently known by it and its projections of the future, about which it cannot be certain. 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.