Now Available in Europe,
parts of the Middle East,
Asia, Latin America, and Africa
- Early customers include GP offices and other community-based
healthcare settings
- Latest figures, released as part of World Diabetes Day, reveal
that 1 in 10 adults are now living with diabetes and nearly half
are undiagnosed1
- The LumiraDx HbA1c test is designed to address the growing
clinical need for accessible and reliable HbA1c testing in
community-based healthcare settings such as primary care, diabetes
clinics, rural clinics, retail pharmacy & other decentralised
healthcare settings
- The actively controlled microfluidic immunoassay is run on the
highly portable LumiraDx Platform and designed for near-patient
testing with connected results in under seven minutes
- The addition of HbA1c to the rapidly growing LumiraDx
test menu, enables the consolidation of multiple instruments to a
single, next-generation point of care Platform; all with a common
workflow
LONDON, Nov. 14, 2022 /PRNewswire/ -- LumiraDx
Limited (Nasdaq: LMDX), a next-generation point of care
diagnostics company, today announced the continued commercial
expansion of its HbA1c test, for professional use across
multiple care settings. Used alongside the LumiraDx Platform, the
test monitors known diabetic patients' HbA1c levels and also serves
as an aid in screening and identifying patients who may be at risk
for developing diabetes. Providing results in under seven
minutes from sample application, the test allows improved
efficiency and convenience with on-the-spot diabetes screening and
monitoring at the patient's side. The company announced the assay
had achieved CE marking in late May of this year.
Today's announcement comes on the heels of today's World
Diabetes Day which called attention to recent figures from the IDF
Diabetes Atlas that 1 in 10 adults now have diabetes and
nearly 1 in 2 are undiagnosed. 1 The portability and
flexibility of the LumiraDx Platform enables the LumiraDx HbA1c
test to address the growing clinical need for accessible and
reliable HbA1c testing in the community healthcare setting to aid
in quicker clinical decision making. 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%
(NGSP) in both capillary and venous whole blood.
David Walton, LumiraDx's Chief
Commercial Officer commented, "As the global prevalence of diabetes
is increasing, it's critical for healthcare professionals to have
access to rapid and reliable HbA1c results. The availability of an
immediate, lab-comparable HbA1c test has been shown to improve
patient outcomes through improved diabetes management.
2,3 In addition, there are a number of well-known
comorbidities associated with diabetes. These are supported through
our multi-assay testing Platform - including tests for cardiac
biomarkers, coagulation, and inflammation- making the LumiraDx
Platform an ideal tool for improving patient outcomes within the
community healthcare setting."
Professor Garry John Consultant Clinical Biochemist,
Norfolk and Norwich University Hospital, current Secretary of
the IFCC Executive Committee of the Scientific Division (SD) and
former Chairperson of the IFCC Working Group for the Global
Standardisation of HbA1c, Honorary Professor, Norwich Medical
School (UEA) explained , "Decentralised diabetes
testing allows people to go to their GP or pharmacy and have these
tests done there. This is important because it allows individuals
to see their results immediately and therefore encourages them to
achieve the target set out for them. It also enables the healthcare
provider to be reassured that the level of improvement or control
is a true representation of the metabolic situation." He continued,
"Basic laboratory support for clinical colleagues providing
healthcare is fundamental; anything that allows our clinical teams
to gather the complete information they need on the patient they
are dealing with at that point in time is central to good metabolic
control."
Johannes Pachler , Managing
Director of Leupamed Medizintechnik GmbH, a leading medical
equipment supplier in Austria
commented, "The HbA1c test is a welcome addition to the LumiraDx
Platform for our customers, which includes more than 100 LumiraDx
Platforms used by GPs and internal medicine groups. We know there
is tremendous value for clinicians being able to share
immediate results with patients - this is particularly true for the
monitoring and screening of diabetes. The intuitive nature of the
Platform and the accurate results of the HbA1c test make it an
important tool for diabetes management and clinicians are already
seeing the positive impact the test can make on patient care. "
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 the pipeline, 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.
References:
1: worlddiabetesday.org/about/facts-figures/
2:
diabetesjournals.org/care/article/22/11/1785/19794/Immediate-feedback-of-HbA1c-levels-improves
3. www.ncbi.nlm.nih.gov/pmc/articles/PMC4933534/
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