LumiraDx Limited 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. 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.