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 95.5% and a negative percent agreement of up to 99.2% versus
RT-PCR, based on clinical data collected 0-12 days since symptom
onset**. For Influenza, the test demonstrated a positive
percent agreement of 83.3% (Flu A) and 80% (Flu B) and a negative
percent agreement of 97.5% (Flu A) and 95.3% (Flu B) versus RT-PCR,
based on retrospective samples collected during 2019-2020 influenza
season. The company has initiated prospective clinical studies to
determine clinical performance.
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
View original content to download
multimedia:https://www.prnewswire.com/news-releases/lumiradx-covid-19--flu-ab-rapid-antigen-test-achieves-ce-marking-301450232.html
SOURCE LumiraDx