LONDON, June 8, 2022
/PRNewswire/ -- LumiraDx Limited (Nasdaq: LMDX) today announced
that it has achieved CE Mark for two new Fast Lab Solutions
molecular tests, including Dual-Target SARS-CoV-2 STAR Complete and
SARS-CoV-2 & Flu A/B RNA STAR Complete. These high-sensitivity
and high-throughput tests help to expand testing capabilities
across the globe.
LumiraDx's continued innovation of its qSTAR technology, which
utilizes a single-step direct method for nucleic acid extraction
and amplification on validated open RT-PCR instruments, has led to
the development of multiplexing capabilities.
The LumiraDx SARS-CoV-2 & Flu A/B RNA STAR Complete assay
allows for the simultaneous detection and differentiation of
influenza A, influenza B, and SARS-CoV-2. SARS-CoV-2 & Flu A/B
RNA STAR Complete compares to high sensitivity RT-PCR with a
positive percent agreement (PPA) of 94.1% for SARS-CoV-2, and 92.3%
for influenza A, and 95.7% for influenza B and a negative percent
agreement (NPA) of >99.5% in symptomatic individuals.
The Dual-Target SARS-CoV-2 STAR Complete multiplex assay
simultaneously detects two gene markers to identify the presence of
SARS-CoV-2, which will meet certain regulatory requirements in
numerous regions that need two or more targets for a COVID-19
diagnostic. Compared to a high sensitivity RT-PCR, Dual-Target
SARS-CoV-2 STAR Complete proved to have a PPA of 97.7% for
SARS-CoV-2 and a NPA of 100% in symptomatic individuals.
"As the pandemic persists, we remain focused on bringing to
market high-quality molecular diagnostics that further remove
testing barriers and enhance laboratory operations," explained
Sanjay Malkani, President of
LumiraDx Fast Lab Solutions. He continued, "We are pleased to
demonstrate unrivaled innovation with direct method,
high-throughput, highly sensitive assays for open molecular
platforms - with results available in 20 minutes - and the added
benefit of accurately detecting influenza and COVID-19 from a
single sample."
About LumiraDx Fast Lab
Solutions
LumiraDx Fast Lab Solutions supports high-complexity laboratory
testing by utilizing its innovative qSTAR nucleic acid
amplification technology in an accessible high-throughput format to
leverage current molecular laboratory operations. Utilizing Fast
Lab Solutions enables laboratories to improve efficiency and reduce
time to result.
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 Fast Lab Solutions molecular tests, including Dual-Target
SARS-CoV-2 STAR Complete and SARS-CoV-2 & Flu A/B RNA STAR
Complete. 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; regulatory changes; the ability of
LumiraDx to maintain CE marking for its Fast Lab Solutions
molecular tests; 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 in 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,
except as required by applicable law.
Media Contact:
Colleen.McMillen@lumiradx.com
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SOURCE LumiraDx