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May 26, 2022

LumiraDx’s HbA1c test receives CE mark for diabetes screening

The automated, quantitative fingerstick assay can deliver results in less than seven minutes from sample application.

LumiraDx has reported that its HbA1c test received CE mark for the screening and monitoring of people with diabetes in the point of care (POC) setting.

The rapid microfluidic immunofluorescence assay is used with the portable LumiraDx Platform and provides results in less than seven minutes from sample application.

Furthermore, the automated, quantitative fingerstick assay can aid in screening and detecting patients at risk of developing diabetes.

Adding HbA1c to the LumiraDx test menu also facilitates the merging of various instruments to a single POC Platform with a shared workflow. 

The new HbA1c test has a reportable range of 20 to 130 mmol/mol HbA1c. 

According to data from an external, multisite clinical trial, the test was shown to attain a precision of ≤2.50% in capillary and venous whole blood as measured by mean paired replicate %CV. 

The company noted that the test is intended to meet the rising clinical demand for reliable HbA1c testing in the community healthcare setting.

The test will be offered on the same POC Platform as the company’s high sensitivity SARS-CoV-2 Antigen, Flu A/B, RSV, SARS-CoV-2 Antibody, SARS-CoV-2 Antigen Pool and SARS-CoV-2 Ag Ultra as well as INR, D-Dimer and CRP tests.

LumiraDx CEO Ron Zwanziger said: “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 centralised and streamlined, connected platform that delivers lab comparable performance.”

The latest development comes after the World Health Organization (WHO) granted Emergency Use Listing (EUL) for the company’s rapid antigen assay for Covid-19 detection.

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