New diagnostic tool for diabetes, SEKURE® receives FDA approval

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Sekisui Diagnostics announces the FDA clearance of their SEKURE® HbA1c assay. The assay has been cleared to be used as an aid in the diagnosis of diabetes mellitus, as an aid in identification of patients at risk for development of diabetes mellitus, and for the monitoring of long-term blood glucose control in individuals with diabetes mellitus.

Hemoglobin A1c (HbA1c) is the most commonly used test to help diagnose and monitor diabetes, a condition that affects 425 million worldwide. With 1 in 4 people in the US unaware they have diabetes, diagnosis and management are important in delaying the progression of disease and its associated side effects.

“We are very excited to announce the clearance of the SEKURE® HbA1c assay”

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 utilises an onboard pretreatment step on Sekisui Diagnostics SK™ 500 Clinical Chemistry System, eliminating time-consuming manual preparation prior to testing. With the FDA clearance, the SEKURE® HbA1c test is now available on the SK500 in both the US as well as the European Union as it previously obtained a CE mark.

Robert Schruender, President & CEO of Sekisui Diagnostics said, “We are very excited to announce the clearance of the SEKURE® HbA1c assay which expands the SK500 Clinical Chemistry System menu and brings a valuable offering to low-to-moderate volume laboratories seeking to automate HbA1c tests on their clinical chemistry system. This system is highly complementary with the rest of our clinical chemistry product line and illustrates our commitment to deliver innovative products which improve patient care.”