– Microfluidic immunofluorescence test authorized for screening asymptomatic individuals using a single test with results available in 12 minutes
– The performance of the assay for the detection of viral antigen in asymptomatic individuals was 82.1% positive agreement and 100% negative agreement compared to laboratory RT-PCR
– The results of clinical studies recently published in the American Journal of Clinical Pathology showed a positive agreement of 100% in asymptomatic individuals below Ct 30 and a positive agreement of 95.8% in individuals below Ct 33
– Large-scale, high-sensitivity testing and screening of asymptomatic people is an important disease mitigation measure in large gatherings, travel, schools and workplaces
LONDON, November 1, 2021 / PRNewswire / – Today, LumiraDx (Nasdaq: LMDX), a next-generation point-of-service diagnostics (POC) company, announced that the intended use of its Emergency Use Authorization (EUA) of the Food and Drug Administration (FDA) authorized the SARS-CoV-2 Antigen Test was expanded to include screening of asymptomatic individuals. This claim builds on its existing claim which covers the use of the test in people suspected of COVID-19 by their health care provider within 12 days of onset of symptoms. The LumiraDx SARS-CoV-2 antigen test initially received EUA from the FDA in August 2020 after demonstrating a positive 97.6% agreement and a 96.6% negative agreement with RT-PCR in symptomatic patients. Asymptomatic individuals are defined as those without symptoms or other epidemiological reasons to suspect COVID-19.
Nigel lindner, PhD, Chief Innovation Officer of LumiraDx explained, âWe understand that one of the most important challenges in keeping infection rates low is being able to quickly and accurately identify SARS-CoV- infection. 2 in asymptomatic individuals. individuals is an essential tool in preventing the transmission of COVID-19. With this clearance from the FDA, we can implement rapid and high sensitivity mass screening programs with our partners in schools, events, workplaces, clinics, travel and other settings and have the test manufacturing capability to support these new test mandates nationwide. “
The FDA cleared the EUA extension for LumiraDx after reviewing the company’s data on the performance of its SARS-CoV-2 antigen test in individual asymptomatic subjects collected between June 2020 and March 2021. Results indicated high sensitivity and specificity in asymptomatic individuals with the LumiraDx SARS-CoV-2 Ag assay, demonstrating a positive agreement of 82.1% and a negative agreement of 100% with the RT-PCR test in 222 subjects. . These results illustrate the high sensitivity offered by a microfluidic test compared to lateral flow SARS-CoV-2 antigen tests, which independent studies have shown to have sensitivities below 50% in asymptomatic populations.1.2
Study results supporting EUA’s claim for asymptomatic use were recently published in the American Journal of Clinical Pathology.3 Lead author of the article, Dr Paul Drain, Departments of Global Health and Medicine, University of Washington, commented: âThe LumiraDx SARS-CoV-2 Antigen test has the advantage of being rapid and sensitive to detect the majority of potentially infected individuals. and helps prevent further transmission.Our study reported a strong agreement between the LumiraDx SARS-CoV-2 Antigen test and the reference RT-PCR test in asymptomatic participants, suggesting that the test is a valuable tool for the rapid screening of symptom-free individuals in community and healthcare settings to limit the spread of COVID-19. He continued, âRapid results are an important part of virus prevention strategies, allowing the identification and isolation of people who are asymptomatic or pre-symptomatic and who might otherwise unknowingly transmit the COVID-19 virus. This strategy may be important in non- traditional testing environments, such as schools, workplaces, events, and airports. “
LumiraDx’s high sensitivity SARS-CoV-2 antigen test was developed on the LumiraDx healthcare platform and is currently in use by CVS Pharmacy Inc in the US, the National Health Service (NHS) and Boots in the UK United, a significant number of accidents and emergency Italy and other parts of Europe, hospital systems Japan and through South America, and is deployed in partnership with the Bill & Melinda Gates Foundation in 48 African countries where access to high quality diagnostics is limited.
The LumiraDx SARS-CoV-2 Antigen test is available in the United States and Europe after receiving Emergency Use Authorization (EUA) initially granted by the United States Food and Drug Administration (FDA) in August 2020 and having obtained the CE mark in August 2020.
About the LumiraDxSARS-CoV-2 Antigen Test
In the United States, the LumiraDxSARS-CoV-2 antigen test has not been authorized or approved by the FDA, but has been cleared by the FDA under an EUA for use by authorized laboratories. The product has only been authorized for the detection of SARS-CoV-2 proteins, not for other viruses or pathogens. Emergency use of the product is only authorized 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 under Section 564 (b) (1) of the Federal Law. Food, Drug, and Cosmetic Act, 21 USC Â§ 360bbb-3 (b) (1), unless the statement is terminated or the authorization is earlier revoked.
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 in the laboratory at the point of care. LumiraDx diagnostic testing solutions are deployed by governments and major healthcare facilities in laboratories, emergency care, physician’s offices, pharmacies, schools and workplaces to screen, diagnose and monitor good -be as well as diseases. LumiraDx has over 30 tests on the market and in development covering infectious disease, cardiovascular disease, 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 and has over 1,500 employees worldwide.
More information on 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. 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 commercial information. conditions; the effect of COVID-19 on LumiraDx’s business and financial results; continued EUA authorization for the LumiraDx SARS-CoV-2 antigen test (as reissued) and the factors discussed under the heading âRisk Factorsâ in the proxy statement and prospectus filed in accordance with the rule 424B(3) with the Securities and Exchange Commission (“SEC”) on September 10, 2021 and other documents filed with the SEC. While LumiraDx believes that there is 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, regarding of which she cannot be certain. LumiraDx assumes 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.
1: Prince-Guerra JL, Almendares O, Nolen LD, et al. Evaluation of the Abbott BinaxNOW Rapid Antigen Test for SARS-CoV-2 Infection at Two Community Testing Sites – Pima County, Arizona, November 3-17, 2020. MMWR Morb Mortal Wkly Rep 2021; 70: 100-105. DOI: http://dx.doi.org/10.15585/mmwr.mm7003e3 external icon
2: Pray IW, Ford L, Cole D, et al. Performance of an antigen-based test for asymptomatic and symptomatic SARS-CoV-2 testing at two university campuses – Wisconsin, September-October 2020. MMWR Morb Mortal Wkly Rep 2021; 69: 1642-1647. DOI: http://dx.doi.org/10.15585/mmwr.mm695152a3 external icon.
3. Drain, P., Sulaiman, R & Hoppers, M. et al. Performance of the LumiraDx point-of-care microfluidic immunofluorescence SARS-CoV-2 antigen test in asymptomatic adults and children. Amer J Clin Pathology Epub 20 octobere 2021 https://doi.org/10.1093/ajcp/aqab173
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