LumiraDx COVID-19 & Flu A/B Rapid Antigen Test Achieves CE Marking
LumiraDx (Nasdaq: LMDX) has announced that its SARS-CoV-2 & Flu A/B Antigen Test has achieved CE Marking, allowing its launch in Europe amidst rising respiratory illness rates. This rapid test boasts a positive agreement of up to 95.5% for SARS-CoV-2 and significant performance for influenza detection. Shipments will begin shortly to aid in differentiating respiratory infections during the critical winter season. The company reassures that its tests remain effective against the Omicron variant. LumiraDx continues to expand its diagnostic capabilities across various diseases.
- Achieved CE Marking for the SARS-CoV-2 & Flu A/B Antigen Test.
- Test shows a positive agreement of up to 95.5% for SARS-CoV-2.
- Significant performance for influenza detection with positive agreements of 83.3% (Flu A) and 80% (Flu B).
- Shipments of the test will begin shortly, targeting the peak respiratory illness season in Europe.
- Reliance on CE Marking as a regulatory achievement may not assure long-term sales success.
- Potential risks associated with the performance of tests against emerging variants like Omicron.
LONDON, Dec. 23, 2021 /PRNewswire/ -- LumiraDx (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced its SARS-CoV-2 & Flu A/B Antigen Test has achieved CE Marking. The microfluidic immunofluorescence assay can quickly verify potential infection for patients suspected of influenza and/or COVID-19, helping to identify and differentiate the underlying cause of respiratory illness and to inform treatment decisions at the point of care. Existing respiratory tests on the LumiraDx Platform include the company's SARS-CoV-2 Antigen, SARS-CoV-2 Antibody and SARS-CoV-2 Antigen Pool tests which achieved CE Marking in August 2020, September 2020 and March 2021, respectively.
For SARS-CoV-2, the test has a positive percent agreement of up to
Shipments of the LumiraDx SARS-CoV-2 & Flu A/B Antigen Test will begin shortly. The test's availability comes at a critical time as Europe has entered respiratory illness season, which typically runs November to April, while continuing to deal with increasing rates of COVID-19. The SARS-CoV-2 & Flu A/B Antigen Test helps distinguish between the viral respiratory infections SARS-CoV-2 and influenza while also differentiating between influenza A and influenza B. This is important as the presenting symptoms overlap and guidance of underlying infection is required in determining appropriate interventions and treatments. The detection of SARS-CoV-2, influenza A, and influenza B viral antigen is direct from nasal swab specimens collected from individuals suspected of viral infection consistent with COVID-19 or influenza-like illness by their healthcare provider.
Ron Zwanziger, LumiraDx's Chief Executive Officer explained, "Our SARS-CoV-2 & Flu A/B Test builds upon the same microfluidic technology used with our highly sensitive SARS-CoV-2 Ag test which has demonstrated market-leading clinical performance. This season, we are not only experiencing increased rates of COVID-19 with the Omicron variant, but also beginning to see influenza activity throughout the European Region for the first time since the pandemic began. Rapid identification of the underlying cause of respiratory illness is important in guiding appropriate clinical decisions, helping to improve patient outcomes and patient workflows."
"In Primary Care, the ability to make fast decisions when your patient is displaying respiratory symptoms will be a great tool. A single test at the point of need that allows us to identify and differentiate the underlying cause, whether it is COVID-19 or influenza, with accuracy – is just what we need," stated Dr. Matthew Fay, Clinical Chief Executive, Affinity Care and GP Principal, The Willows Medical Practice in the UK.
Last month, LumiraDx announced that based on detailed analysis of the specific mutations in the Omicron variant, it was confident that the performance of the company's antigen and molecular tests would not be impacted by these mutations.
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 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 & Flu A/B 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 approval for the SARS-CoV-2 & Flu A/B Antigen 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.
* Not all tests are available in all countries and regions. For additional detail on product availability please visit www.lumiradx.com
** See LumiraDx SARS-CoV-2 & Flu A/B Product Insert for more details
Media Contact:
Colleen McMillen
Colleen.McMillen@lumiradx.com
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SOURCE LumiraDx
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