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LumiraDx Obtains CE Mark for Point-of-Care HbA1c Test

NEW YORK ─ LumiraDx on Thursday announced it has obtained CE marking for its HbA1c test, a rapid microfluidic assay that runs on its point-of-care platform.

The automated, quantitative immunofluorescence assay provides results in less than seven minutes for the monitoring of individuals with diabetes and to aid in the screening and identification of patients who may be at risk for developing the condition, the firm said.

The test has a reportable range of 20 to 130 mmol/mol HbA1c and operates using capillary and venous whole blood, addressing a growing clinical need for accessible and reliable HbA1c testing in the community healthcare setting, LumiraDx said.

"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," Ron Zwanziger, LumiraDx's CEO, said in a statement.

Last week, London-based LumiraDx announced it had obtained CE marking for its five-minute SARS-CoV-2 Ag Ultra Test.