LumiraDx Lab Analysis Confirms its COVID-19 Antigen Test Detects the Omicron Variant

LumiraDx

2022/1/14 20:23

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 (

https://c212.net/c/link/?t=0&l=en&o=3413062-1&h=1192575092&u=https%3A%2F%2Fwww.lumiradx.com%2Fus-en%2Fnews-events%2Flumiradx-monitoring-of-new-and-emerging-variants-of-concern-and-detection-of-the-omicron-variant&a=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.

 

Logo - https://mma.prnewswire.com/media/1675669/LumiraDx_Logo.jpg

 

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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