LONDON, May 20, 2022 /PRNewswire/ -- LumiraDx
Limited (Nasdaq: LMDX), a next-generation point of care diagnostics
company, announced today that its rapid COVID-19 antigen assay,
LumiraDx SARS-CoV-2 Ag Test has
successfully received the Emergency Use Listing (EUL) by the World
Health Organization (WHO) in their latest response effort to combat
COVID-19.
The LumiraDx antigen test is a microfluidic immunofluorescence
assay that delivers results for the direct and qualitative
detection of nucleocapsid protein antigen in nasal swab specimens
collected from the patient. Used with the LumiraDx multi-assay
Platform, the test delivers rapid results at the point of care
enabling physicians to immediately commence appropriate treatment
and patient management to maximize health outcomes and minimize
further spread of infection.
"The ongoing complexities of the evolving pandemic require
multiple lines of defense," said Dr Nigel
Lindner, Chief innovation Officer. "This important milestone
lets us offer a reliable and affordable, high-performance testing
alternative to better manage the pandemic burden and help reduce
the strain on health systems worldwide."
Through a partnership with the Bill and Melinda Gates
Foundation, LumiraDx has already distributed 5,000 Platforms in 49
African countries in a variety of care settings, including field
clinics, airports, primary healthcare facilities, occupational
health settings, and walk-through clinics. In addition to its
SARS-CoV-2 Ag test, other assays in LumiraDx's pipeline
for TB, diabetes, HIV-AIDS and other health conditions have the
potential to make a meaningful impact on global health.
The decision by the WHO to include the LumiraDx SARS-CoV-2
antigen test in its EUL was based on an essential set of available
quality, safety, and efficacy and performance data. In clinical
studies the test demonstrated 95% positive agreement versus RT-PCR
in patients tested within 12 days of the onset of symptoms.
The LumiraDx antigen test joins a select group of antigen
tests the WHO has included in its Emergency Use Listing and
represents the first microfluidic assay to meet the criteria.
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 Ag test and about
LumiraDx's pipeline of future products. 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 and those factors
discussed under the header "Risk Factors" in the Annual Report on
Form 20-F for the year ended December
31, 2021, which was filed by LumiraDx with the Securities
and Exchange Commission ("SEC") on April 13,
2022, and other filings made by LumiraDx 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.
Contact:
Colleen.McMillen@lumiradx.com
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