LumiraDx Submits First 510(k) Application to the FDA for COVID Ultra Test
01 July 2023 - 4:30AM
LumiraDx Limited (Nasdaq: LMDX), a leading innovator in diagnostic
technologies, today announced the submission of its first 510(k)
application to the U.S. Food and Drug Administration (FDA) for the
clearance of its ground-breaking 5-minute COVID Ultra Test.
LumiraDx submitted a traditional 510(k) Dual Submission for
LumiraDx SARS-CoV-2 Ag Ultra with CLIA Waiver for the commercial
distribution at point of care of the LumiraDx Platform, including
the LumiraDx Instrument, with the LumiraDx SARS-CoV-2 Antigen (Ag)
Ultra test, and the LumiraDx SARS-CoV-2 Ag Quality Control Swab
Kit.
This significant milestone marks a crucial step
forward in continued access and expansion into the United States
for the LumiraDx Platform. LumiraDx had earlier received various
Emergency Use Authorizations (EUA) for its SARS-CoV-2 Ag tests
during the pandemic. This is the first time the LumiraDx Instrument
has been submitted for 510(k) review and the submission underscores
LumiraDx’s continued commitment to providing a complete solution
that meets the highest standards of performance and safety. Once
reviewed, this submission should facilitate further submissions to
the FDA with focus switching from the LumiraDx Instrument to assay
components.
The LumiraDx SARS-CoV-2 Ag Ultra Test is a
state-of-the-art diagnostic test that leverages LumiraDx's
cutting-edge technology to detect the presence of SARS-CoV-2, the
virus responsible for COVID-19. Built upon a robust scientific
foundation, the test demonstrates exceptional accuracy and
reliability, ensuring confidence in its results. The test is
already available in Europe and various international markets.
"We are thrilled to announce the submission of our first 510(k)
application to the FDA for the clearance of our COVID Ultra Test,"
said Carol Adiletto-Francis, Global SVP, Clinical Regulatory &
Quality at LumiraDx. "LumiraDx remains committed to delivering
innovative diagnostic solutions that address critical healthcare
needs. The submission of this first 510(k) application represents a
significant milestone in the company's journey towards receiving
FDA approval for the COVID Ultra Test. This also forms the
foundation for additional submissions of other high performing
assays on the same Platform, many of which are available in Europe
and elsewhere and others which are in late stages of
development.”
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 Platform and the LumiraDx SARS-CoV-2 Antigen (Ag)
Ultra test, and the timing, scope or likelihood of regulatory
submissions, filings, approvals, authorizations, certifications,
clinical trials or clearances, including our ability to
successfully transition any test that has previously been
authorized by the FDA under an EUA declaration related to COVID-19,
to the required FDA marketing submission (e.g., 510(k), de novo or
PMA) on a timely basis, or at all. 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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