LumiraDx Announces the Intended Use for its FDA EUA Authorized High Sensitivity COVID-19 Antigen Test has been Expanded to Include Testing of Asymptomatic Individuals
- Microfluidic immunofluorescence assay authorized for screening asymptomatic individuals using a single test with results available in 12 minutes
- The test performance for viral antigen detection in asymptomatic individuals was 82.1% positive agreement and 100% negative agreement compared to laboratory RT-PCR
- Recently published clinical study results in the American Journal of Clinical Pathology showed 100% positive agreement in asymptomatic individuals below Ct 30 and 95.8% positive agreement in individuals below Ct 33
- Wide-spread, high-sensitivity testing and screening of asymptomatic individuals is an important disease mitigation measure at large event gatherings, travel, school, and the workplace
LONDON, Nov. 1, 2021 /PRNewswire/ -- Today, LumiraDx (Nasdaq: LMDX) a next-generation point of care (POC) diagnostics company announced that the intended use for its Food and Drug Administration (FDA) Emergency Use Authorization (EUA) authorized SARS-CoV-2 Antigen Test has been expanded to include screening of asymptomatic individuals. This claim builds on its existing claim that covers use of the test in individuals suspected of COVID-19 by their healthcare provider within 12 days of symptom onset. The LumiraDx SARS-CoV-2 Antigen Test initially received EUA from the FDA in August of 2020 after demonstrating a 97.6% positive agreement and 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, LumiraDx Chief Innovation Officer explained, "We understand that one of the most important challenges in keeping infection rates low is to be able to quickly and accurately identify SARS-CoV-2 infection in asymptomatic individuals. Widespread testing in both symptomatic and asymptomatic individuals is a critical tool in preventing transmission of COVID-19. With this FDA authorization we can enable rapid, high sensitivity mass screening programs with our partners across schools, events, workplaces, clinics, travel and other settings and have the testing manufacturing capacity to support these new nation-wide testing mandates."
The FDA authorized the expansion of the EUA for LumiraDx after reviewing company 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 Test, demonstrating an 82.1% positive agreement and 100% negative agreement with RT-PCR test in 222 subjects. These results illustrate high sensitivity offered by a microfluidic test compared to lateral flow SARS-CoV-2 antigen tests, which independent studies have shown to have sensitivities of less than 50% in asymptomatic populations.1,2
The study results supporting the EUA claim for asymptomatic use were recently published in the American Journal of Clinical Pathology.3 Lead author of the paper, Dr. Paul Drain, Departments of Global Health and Medicine, University of Washington, commented, "The LumiraDx SARS-CoV-2 Antigen test has the advantage of speed with the sensitivity to detect the majority of potentially infected individuals and aid in the prevention of onward transmission. Our study reported high 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 individuals without symptoms in both community and health care settings to limit the spread of COVID-19." He continued, "Rapid results are an important part of virus prevention strategies, enabling the identification and isolation of persons who are asymptomatic or pre-symptomatic and who might otherwise be unknowingly transmitting the COVID-19 virus. This strategy may be important in non-traditional testing settings, such as schools, workplaces, events and airports."
LumiraDx's high sensitivity SARS-CoV-2 Antigen Test was developed on the LumiraDx point of care platform and is currently being used by CVS Pharmacy Inc in the U.S., the National Health Service (NHS) and Boots in the UK, a significant number of accident and emergency rooms in Italy and other parts of Europe, hospital systems in Japan and across South America, and is being deployed in partnership with the Bill & Melinda Gates Foundation in 48 African countries where access to high quality diagnostics is limited.
LumiraDx SARS-CoV-2 Antigen test has been available in the US and Europe after receiving Emergency Use Authorization (EUA) originally granted by the U.S. Food and Drug Administration (FDA) in August 2020 and having obtained CE Mark in August 2020.
About the LumiraDxSARS-CoV-2 Antigen Test
In the USA, the LumiraDxSARS-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.
About LumiraDx
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 1500 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. 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 424B(3) with the Securities and Exchange Commission ("SEC") on September 10, 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.
1: Prince-Guerra JL, Almendares O, Nolen LD, et al. Evaluation of Abbott BinaxNOW Rapid Antigen Test for SARS-CoV-2 Infection at Two Community-Based 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.mm7003e3external 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.mm695152a3external icon.
3. Drain, P., Sulaiman, R & Hoppers, M. et al. Performance of the LumiraDx Microfluidic Immunofluorescence Point-of-Care SARS-CoV-2 Antigen Test in Asymptomatic Adults and Children. Amer J Clin Pathology Epub Oct 20th 2021 https://doi.org/10.1093/ajcp/aqab173
Media contact:
Colleen McMillen
Colleen.mcmillen@lumiradx.com
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