LumiraDx Receives UK CTDA Approval for COVID Ultra and COVID & RSV Tests
21 June 2023 - 6:15AM
LumiraDx Limited (Nasdaq: LMDX) today announced that it has
received validation for use by the MHRA under the CTDA process for
the LumiraDx SARS-CoV-2 Ag Ultra and LumiraDx SARS-CoV2 Ag &
RSV tests. This milestone supports the UK in preparing for the
upcoming respiratory season with tests that allow for rapid
detection of SARS-CoV-2 infection as well as helping to
differentiate between SARS-CoV-2 and RSV when respiratory symptoms
are present.
The LumiraDx SARS-CoV-2 Ag Ultra test allows for detection of
SARS-CoV-2 infection within 5 minutes, making it a powerful tool at
the point of care. The test enables clinicians to accurately and
confidently test more patients, optimise clinical workflows and
help triage patients without delay. The LumiraDx SARS-CoV2 Ag &
RSV test allows for simultaneous detection and differentiation of
RSV and SARS-CoV-2 infections. Clinical signs and symptoms of
respiratory viral infection due to SARS-CoV-2 and RSV can be
similar, and as RSV normally affects young infants, it is essential
to correctly identify them to treat and manage patients
accordingly.
LumiraDx launched the LumiraDx SARS-CoV-2 Ag Ultra assay in the
European Union and other markets that accept CE-IVD in May 2022 and
the LumiraDx SARS-CoV-2 Ag & RSV assay in May 2022. The company
expects to begin commercialisation of these tests in the UK and
commence commercial shipments imminently.
“With planning for the respiratory season already underway in
some regions, we are delighted to have these tests commercially
available for the NHS and other customers,” explains David Walton,
LumiraDx’s Chief Commercial Officer. “By providing rapid, high
sensitivity point of care tests for COVID, Flu and RSV, we hope to
reduce the burden of respiratory illness, facilitate optimised
clinical workflows and improve patient outcomes.”
About LumiraDx
LumiraDx Limited (Nasdaq: LMDX) is a next-generation point of
care diagnostics company that is transforming community-based
healthcare. Its actively controlled microfluidic technology
provides fast, high performance and accessible diagnostic solutions
wherever the patient is for nearly any testing scenario, creating
unique testing options at the point of need. The company offers a
broad menu of lab comparable tests on a single portable Platform,
with more than 30 assays on the market and in various stages of
development, covering infectious diseases, cardiovascular diseases,
diabetes, and coagulation disorders. The company also supports
high-complexity laboratory testing in an accessible high-throughput
format to leverage current molecular laboratory operations. Founded
in 2014 and based in the UK, LumiraDx's diagnostic testing
solutions are being deployed globally by governments and leading
healthcare institutions across laboratories, urgent care, physician
offices, pharmacies, schools, and workplaces to help screen,
diagnose, and monitor wellness as well as disease. More information
on LumiraDx 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 LumiraDx SARS-CoV-2 Ag Ultra and LumiraDx SARS-CoV2 Ag &
RSV tests and the timing of commercial launch and shipments of
certain products. 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; changes in interest rates, inflation rates
and global and domestic market conditions; the effect of COVID on
our business and financial results; obtaining or maintaining
regulatory approval, authorization or clearance for our tests; and
those factors discussed under the header "Risk Factors" in our
Annual Report on Form 20-F for the year ended December 31, 2022,
which was filed with the Securities and Exchange Commission, or
SEC, on May 1, 2023, and in other filings that we make 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
Media Contact investors@lumiradx.com
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