LumiraDx HbA1c Assay Screens and Identifies Patients at Risk for Developing Diabetes

Rising global rates of diabetes presents growing need for broader access and an easier, more connected solution for HbA1c testing in community-based healthcare settings such as primary care and retail pharmacy. The increase in global health expenditure due to diabetes has been considerable in recent years, growing from USD 232 billion in 2007 to USD 966 billion in 2021 for adults aged 20-79 years – an increase of 316% over the last 15 years. By offering both broader access and an easier, more connected solution for HbA1c testing, patients who might be at risk of developing diabetes can manage their condition sooner, potentially leading to less strain on healthcare systems. Now, a new rapid microfluidic immunofluorescence assay is designed to address the growing clinical need for accessible and reliable HbA1c testing in the community healthcare setting.

LumiraDx’s (London, UK) HbA1c test is an automated, quantitative fingerstick assay that is run on its highly portable LumiraDx Platform. It is intended for the monitoring of individuals with diabetes, and as an aid in screening and identifying patients who may be at risk for developing diabetes. Used with the LumiraDx Platform, the test provides results in less than seven minutes from sample application for the monitoring of individuals with diabetes, and as an aid in screening and identifying patients who may be at risk for developing diabetes, all at the point of care.

The addition of HbA1c to the LumiraDx test menu, enables the consolidation of multiple instruments to a single, next generation POC Platform with a common workflow. 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% in both capillary and venous whole blood.

"With our growing test menu, the LumiraDx Platform is able to quickly and accurately support clinicians with a variety of diagnostic and treatment decisions at the point of care," said Ron Zwanziger, LumiraDx's Chief Executive Officer commented. "HbA1c is an important addition to our Platform not only for our existing pharmacy and primary care customers, but for new customers looking to consolidate their current testing needs into one centralized and streamlined, connected Platform that delivers lab comparable performance."

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