PR98798

LONDON, November 14, 2021 /PRNewswire=KYODO JBN/--

- 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 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

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/

[https://worlddiabetesday.org/about/facts-figures/]

2:

diabetesjournals.org/care/article/22/11/1785/19794/Immediate-feedback-of-HbA1c-l

evels-improves

[https://diabetesjournals.org/care/article/22/11/1785/19794/Immediate-feedback-o

f-HbA1c-levels-improves]

3. www.ncbi.nlm.nih.gov/pmc/articles/PMC4933534/

[https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4933534/]

SOURCE: LumiraDx