May 20, 2022 (London): LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care diagnostics company, announced today that its rapid COVID-19 antigen assay, LumiraDx SARS-CoV-2 Ag Test has successfully received the Emergency Use Listing (EUL) by the World Health Organization (WHO) in their latest response effort to combat COVID-19.
The LumiraDx antigen test is a microfluidic immunofluorescence assay that delivers results for the direct and qualitative detection of nucleocapsid protein antigen in nasal swab specimens collected from the patient. Used with the LumiraDx multi-assay Platform, the test delivers rapid results at the point of care enabling physicians to immediately commence appropriate treatment and patient management to maximize health outcomes and minimize further spread of infection.
“The ongoing complexities of the evolving pandemic require multiple lines of defense,” said Dr Nigel Lindner, Chief innovation Officer. “This important milestone lets us offer a reliable and affordable, high-performance testing alternative to better manage the pandemic burden and help reduce the strain on health systems worldwide.”
Through a partnership with the Bill and Melinda Gates Foundation, LumiraDx has already distributed 5,000 Platforms in 49 African countries in a variety of care settings, including field clinics, airports, primary healthcare facilities, occupational health settings, and walk-through clinics. In addition to its SARS-CoV-2 Ag test, other assays in LumiraDx’s pipeline for TB, diabetes, HIV-AIDS and other health conditions have the potential to make a meaningful impact on global health.
The decision by the WHO to include the LumiraDx SARS-CoV-2 antigen test in its EUL was based on an essential set of available quality, safety, and efficacy and performance data. In clinical studies the test demonstrated 95% positive agreement versus RT-PCR in patients tested within 12 days of the onset of symptoms. The LumiraDx antigen test joins a select group of antigen tests the WHO has included in its Emergency Use Listing and represents the first microfluidic assay to meet the criteria.
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 performance and benefits of the SARS-CoV-2 Ag test and about LumiraDx’s pipeline of future products. 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 and those factors discussed under the header "Risk Factors" in the Annual Report on Form 20-F for the year ended December 31, 2021, which was filed by LumiraDx with the Securities and Exchange Commission ("SEC") on April 13, 2022, and other filings made by LumiraDx 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.