LumiraDx Limited (NASDAQ: LMDX) confirmed that its Hba1c has earned CE marking. HbA1c is a critical addition to its platform, not just for its current pharmacy and primary care customers, but also for potential customers wishing to combine their current testing needs into a single, simplified, connected platform that produces lab-like results.
Diabetes-related global health spending has increased significantly in recent years, rising from USD 232 billion in 2007 to USD 966 billion in 2021 for individuals aged 20–79 years, a 316 percent increase over the last 15 years. Patients who are at risk of getting diabetes may be able to start managing their illness sooner if HbA1c testing is made easier and more linked. This could result in a reduced load on healthcare systems.
It has been disclosed that the test, when used with the LumiraDx Platform, gives findings in under seven minutes from sample application for diabetes monitoring as well as monitoring and identifying patients who may be at risk for diabetes at the point of treatment. With the inclusion of HbA1c in the LumiraDx test menu, various instruments may be consolidated into a single, next-generation POC Platform with a standardized workflow. The LumiraDx HbA1c test provides a range of 20 to 130 mmol/mol HbA1c that can be reported (4.0 - 14.0 percent HbA1c).
Furthermore, in an external, multi-site clinical investigation, the test attained a precision of 2.50 percent in both capillary and venous whole blood, as measured by mean paired replicate percent CV. The LumiraDx HbA1c test was created to meet the rising clinical need for convenient and accurate HbA1c testing in community settings.