LumiraDx Limited (Nasdaq: LMDX), a next-generation point of care diagnostics company, today announced its HbA1c test has achieved CE Marking. Used with the LumiraDx Platform, the test provides results in under 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. The LumiraDx HbA1c test is designed to address the growing clinical need for accessible and reliable HbA1c testing in the community healthcare setting.
Ron Zwanziger, LumiraDx’s Chief Executive Officer commented, “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. 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.”

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 years1. By offering both broader access and an easier, more connected solution for HbA1c testing, patients who might be at risk of developing diabetes may begin to manage their condition sooner, potentially leading to less strain on healthcare systems.

Source: Company Press Release