LumiraDx Announces FDA EUA Submission for its SARS-CoV-2 & Flu A/B Rapid Antigen Test
LumiraDx (Nasdaq: LMDX) announced on October 15, 2021, the submission of its LumiraDx SARS-CoV-2 & Flu A/B Test to the FDA for Emergency Use Authorization. This test is designed to simultaneously detect SARS-CoV-2, Influenza A, and Influenza B, expediting diagnosis for patients within 12 days of symptom onset. The test is part of a broader platform offering multiple assays, with five currently on the market and ten more planned for regulatory submission by 2022. The initiative is supported by funding from the NIH RADx program.
- Submission of the LumiraDx SARS-CoV-2 & Flu A/B Test to the FDA for Emergency Use Authorization, potentially opening new market opportunities.
- The rapid test can enhance clinical decision-making during the flu season, addressing a critical healthcare need.
- Forward-looking statements highlight risks associated with EUAs and potential impacts of COVID-19 on company performance.
LONDON, Oct. 15, 2021 /PRNewswire/ -- LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostic company, today announced it has submitted the LumiraDx SARS-CoV-2 & Flu A/B Test to the Food and Drug Administration (FDA) for Emergency Use Authorization (EUA). The microfluidic immunofluorescence assay can quickly verify infection for patients suspected of flu and/or COVID-19 to aid diagnosis and clinical decision making.
Run on the LumiraDx Point of Care Platform, the LumiraDx SARS-CoV-2 & Flu A/B Test is a rapid microfluidic immunofluorescence assay intended for the simultaneous detection of SARS-CoV-2, Influenza A, and Influenza B viral antigen direct from self or clinician collected nasal swab specimens from individuals suspected of viral infection consistent with COVID-19 by their healthcare provider within the first 12 days of the onset of symptoms.
Ron Zwanziger, LumiraDx Chief Executive Officer explained, "Both COVID and Flu infections can present with similar symptoms, but the clinical pathways are different. As we approach the flu season, fast and reliable multi-analyte diagnostic testing may allow healthcare professionals to better triage patients and guide optimal treatment decisions."
The SARS-CoV-2 & Flu A/B Test is one of a growing number of assays run on the LumiraDx Platform. The company currently has five tests in the market globally, and an additional 10 tests scheduled for regulatory submission or clearance by the end of 2022, including tests for troponin and congestive heart failure.
The LumiraDx SARS-CoV-2 & Flu A/B Test is supported by the NIH Rapid Acceleration of Diagnostics (RADxSM) initiative and has been funded in part with Federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92021C00034.
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.
About the LumiraDx SARS-CoV-2 Ag test and LumiraDx SARS-CoV-2 Ab test
The LumiraDx SARS-CoV-2 Ag test and the LumiraDx SARS-CoV-2 Ab test have not been cleared or approved by FDA. The LumiraDx SARS-CoV-2 Ag test has been authorized by FDA under an EUA only for the detection of SARS-CoV-2 nucleocapsid protein. The LumiraDx SARS-CoV-2 Ab test has been authorized by FDA under an EUA only for detecting the presence of total antibodies to SARS-CoV-2. They have not been authorized for use to detect any other viruses or pathogens. The tests are authorized in the United States for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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 & Flu A/B Test and expectations regarding the regulatory submission or clearance of additional tests. 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; obtaining or maintaining EUA approval for the LumiraDx SARS-CoV-2 & Flu A/B Test 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.
Media Contact:
Colleen McMillen
Colleen.mcmillen@lumiradx.com
+1.917.344.9360
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SOURCE LumiraDx Limited
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