LumiraDx Continues Commercial Expansion of its Rapid Microfluidic Immunoassay HbA1c Test
November 14 2022 - 2:58AM
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 LumiraDxLumiraDx Limited (Nasdaq: LMDX)
is 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-improves3.
www.ncbi.nlm.nih.gov/pmc/articles/PMC4933534/
Contact:Colleen
McMillenColleen.McMillen@lumiradx.com+1.917.344.9360
A photo accompanying this announcement is available at
https://www.globenewswire.com/NewsRoom/AttachmentNg/e24265c7-f665-478a-92bd-b0f8f1bf9b53
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