New assay achieves CE Mark Certification and U.S. FDA 501(k) Clearance
BREA, California, March 7, 2019 /PRNewswire/ -- Beckman Coulter, a global leader in the clinical diagnostics industry, today announced the latest addition to its comprehensive chemistry assay menu—the fully automated hemoglobin A1c (HbA1c) Advanced assay. The new assay enables mid- to high-volume laboratories to provide physicians with state-of-the-art precision and accuracy for diagnosing diabetes, monitoring long-term glucose control and identifying patients who may be at risk of developing diabetes.
Now available on the DxC 700 AU, the HbA1c Advanced assay offers greater laboratory efficiency by eliminating manual sample preparation. The addition of the new assay enables laboratories to integrate whole blood analysis with their existing routine and STAT samples to deliver optimized turnaround time.
"Early diagnosis of diabetes increases an individual's chances of preventing harmful and costly complications," said Puneet Sarin, senior vice president, clinical chemistry and immunoassay, Beckman Coulter. "Because 50% of people with diabetes are undiagnosed, there is an urgent need to identify and provide appropriate care for individuals with the disease. We developed the HbA1c Advanced assay to help fill this need and deliver the clinically effective results physicians require when diagnosing and monitoring diabetes."
Today, an estimated 425 million people worldwide—or 8.8% of adults between the ages of 20 and 79—have diabetes. If the current growth trend continues, 629 million people in this demographic will have the disease by the year 2045.
Determination of HbA1c in the blood provides an important means by which to diagnose diabetes and monitor the effectiveness of dietary constraint and other therapies used in diabetes management. In recent validation studies, the new HbA1c Advanced assay demonstrated world-class Six-Sigma performance. A high Sigma metric translates into fewer analytical errors and questionable test results.
Beckman Coulter's new HbA1c Advanced assay exemplifies its commitment to accelerating healthcare by providing clinical partners with an impactful menu that matters, and solutions that address prevalent and expensive health risks. The new assay kit recently received U.S. FDA 501(k) clearance and CE mark certification, and is available for use on Beckman Coulter's recently launched DxC 700 AU chemistry analyzer.
For more information about Beckman Coulter's comprehensive chemistry assay menu or other chemistry and immunoassay solutions, visit https://BeckmanCoulter.com/hemoglobin-a1c.
About Beckman Coulter Diagnostics
Beckman Coulter Diagnostics helps healthcare and laboratory professionals provide better patient care by delivering the accurate diagnostic information they need, when they need it. With a rich 80-year history, Beckman Coulter is a strong partner for healthcare organizations. Our scalable instruments, comprehensive diagnostic tests and business management services are trusted by hospitals, laboratories and other critical care settings around the world. We share in our customers' mission toward continuous improvement and quality patient care because we believe when efficiency and clinical outcomes are improved, patients benefit and we can move healthcare forward for every person.
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SOURCE Beckman Coulter Diagnostics