LumiraDx Lab Analysis Confirms its COVID-19 Antigen Test Detects the Omicron Variant
PR94064
LONDON, Jan. 14, 2022 /PRNewswire=KYODO JBN/ --
--Results from ongoing testing and monitoring of COVID-19 variants shows the
rapid microfluidic test detects Omicron at a comparable sensitivity to other
variants
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.
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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. Section 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
SOURCE: LumiraDx
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