Next-generation point of care diagnostics company LumiraDX has announced the continued commercial expansion of its HbA1c test, for professional use across multiple care settings.
The test, which is used alongside the LumiraDx Platform, 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.
By 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.
LumiraDX announced the assay had achieved CE marking in late May of this year.
The announcement comes in time for today’s World Diabetes Day, which called attention to recent figures from the IDF Diabetes Atlas that one in 10 adults now have diabetes and nearly one in two are undiagnosed.
The portability and flexibility of the LumiraDx Platform enables the LumiraDx HbA1c test to address a 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 HbA1c 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), said:
“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.
“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 said:
“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.”
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