Country for PR: United Kingdom
Contributor: PR Newswire Europe
Tuesday, November 15 2022 - 03:14
LumiraDx Continues Commercial Expansion of its Rapid Microfluidic Immunoassay HbA1c Test
LONDON, November 14, 2021 /PRNewswire-AsiaNet/--

- Now Available in Europe, parts of the Middle East, Asia, Latin America, and 

- Early customers include GP offices and other community-based healthcare 

- Latest figures, released as part of World Diabetes Day, reveal that 1 in 10 
adults are now living with diabetes and nearly half are undiagnosed[1]

- 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

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 

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 



SOURCE: LumiraDx