- Rapid microfluidic immunofluorescence assay intended for the
monitoring of individuals with diabetes, and as an aid in screening
and identifying patients who may be at risk for developing
diabetes
- The automated, quantitative fingerstick assay is run on the
highly portable LumiraDx Platform and designed for near-patient
testing with connected results in under seven minutes
- Rising global rates of diabetes presents growing need for
broader access and an easier, more connected solution for HbA1c
testing in community-based healthcare settings such as primary care
and retail pharmacy
- Available on the same Point of Care (POC) Platform as
LumiraDx's high sensitivity SARS-CoV-2 Antigen, Flu A/B, RSV,
SARS-CoV-2 Antibody, SARS-CoV-2 Antigen Pool, SARS-CoV-2 Ag Ultra
as well as INR, D-Dimer and CRP tests*
LONDON, May 26, 2022 /PRNewswire/ -- LumiraDx Limited
(Nasdaq: LMDX), a next-generation point of care diagnostics
company, today announced its HbA1c test has achieved CE Marking.
Used with the LumiraDx Platform, the test provides results in under
seven minutes from sample application for the monitoring of
individuals with diabetes, and as an aid in screening and
identifying patients who may be at risk for developing diabetes,
all at the point of care.
The addition of HbA1c to the LumiraDx test menu, enables the
consolidation of multiple instruments to a single, next generation
POC Platform with a common workflow. The LumiraDx HbA1c test
has a reportable range of 20 - 130 mmol/mol HbA1c (4.0 - 14.0%
HbA1c). In an external, multi-site clinical study, the test
achieved precision, expressed as mean paired replicate %CV, of
≤2.50% in both capillary and venous whole blood. The LumiraDx HbA1c
test is designed to address the growing clinical need for
accessible and reliable HbA1c testing in the community healthcare
setting.
Ron Zwanziger, LumiraDx's Chief Executive Officer commented,
"With our growing test menu, the LumiraDx Platform is able to
quickly and accurately support clinicians with a variety of
diagnostic and treatment decisions at the point of care. HbA1c is
an important addition to our Platform not only for our existing
pharmacy and primary care customers, but for new customers looking
to consolidate their current testing needs into one centralized and
streamlined, connected Platform that delivers lab comparable
performance."
The increase in global health expenditure due to diabetes has
been considerable in recent years, growing from USD 232 billion in 2007 to USD 966 billion in 2021 for adults aged 20–79
years – an increase of 316% over the last 15 years1. By
offering both broader access and an easier, more connected solution
for HbA1c testing, patients who might be at risk of developing
diabetes may begin to manage their condition sooner, potentially
leading to less strain on healthcare systems.
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 LumiraDx HbA1c 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; regulatory changes;
the ability of LumiraDx to maintain CE marking for its HbA1c test;
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 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.
* Not all tests are available in all countries and regions. For
additional detail on product availability please visit
www.lumiradx.com.
- IDF Diabetes Atlas, 10th Edition - 2021
Media Contact:
Colleen McMillen
Colleen.McMillen@lumiradx.com
Photo -
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