LONDON, Jan. 14, 2022 /PRNewswire/ -- LumiraDx
(Nasdaq: LMDX), a next-generation point of care diagnostics
company, today announced that results from ongoing testing and
monitoring of COVID-19 variants show its SARS-CoV-2 Antigen test
detects the Omicron Variant. In-house wet testing with live
Omicron virus demonstrated that the LumiraDx SARS-CoV-2 Antigen
test detects the Omicron variant with comparable sensitivity to
other variants. In the original U.S. Food and Drug
Administration ("FDA") Emergency Use Authorization
("EUA") clinical studies, the test demonstrated 100% agreement
with RT-PCR up to Ct 33.0. These latest testing results confirm the
company's previous announcement based on in-silico and
recombinant protein analysis of the specific mutations in the
Omicron variant that it was confident that the performance of its
antigen and molecular tests will not be impacted by these
mutations.
Nigel Lindner, PhD, Chief
Innovation Officer at LumiraDx commented, "Testing is a critical
tool to control the spread of the virus and we have been committed
to conducting research that confirms the sensitivity of our tests
as soon as new variants emerge. We continuously monitor for
COVID-19 variants and evaluate new ones as they appear through our
in-house testing as well as through our collaborations with
laboratory partners globally. The ability of our test to detect
Omicron and other variants of concern, combined with both CE
Marking and EUA from FDA with the intended use that includes
the screening of asymptomatic individuals makes the LumiraDx
SARS-CoV-2 Antigen test a valuable tool at this stage of the
pandemic."
About the LumiraDx SARS-CoV-2 Antigen Test
The LumiraDx SARS-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 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 benefits of the LumiraDx
SARS-CoV-2 Antigen test and its ability to detect variants and
mutations of COVID-19. 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 424(b)(3) with the Securities and Exchange Commission ("SEC")
on September 3, 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
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SOURCE LumiraDx