Therapy Areas: Diabetes
Sekisui Diagnostics' SEKURE HbA1c assay for diabetes mellitus diagnosis wins US FDA clearance
31 July 2018 -

Diagnostics company Sekisui Diagnostics reported on Monday the receipt of US FDA clearance for its SEKURE HbA1c assay for the diagnosis of diabetes mellitus, identification of patients at risk for development of diabetes mellitus as well as for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.

The company said the Hemoglobin A1c (HbA1c) is the most commonly used test to help diagnose and monitor diabetes, a condition that affects over 30 million people in the US and 425 million worldwide.

According to the company, the SEKURE HbA1c assay is used in clinical laboratories to measure the percent concentration of HbA1c (NGSP) or the HbA1c fraction mmol/mol (IFCC) in human venous whole blood and hemolysate. It is an enzymatic assay which is NGSP certified and utilizes an onboard pretreatment step on Sekisui Diagnostics SK 500 Clinical Chemistry System, eliminating time-consuming manual preparation prior to testing.

Following the US FDA clearance, the SEKURE HbA1c test is now available on the SK500 in both the US as well as the EU, where it has obtained a CE mark, concluded the company.