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
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.
The study results supporting the EUA claim for asymptomatic use were recently published in the American Journal of Clinical Pathology. 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.