Beckman Coulter Secures FDA Clearance for Heart Failure Assay on DxI 9000 Immunoassay Analyzer

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May 29, 2024, 08:30 ET

New Access NT-proBNP Assay Detects Heart Failure Biomarker in Less than 11 Minutes

Patient Results Evaluated Within Context of Clinically Relevant
Age-Based Cutoffs, Disease Comorbidity Data and Gender Parameters

BREA, Calif., May 29, 2024 /PRNewswire/ -- Beckman Coulter, a global leader in clinical diagnostics, today announced U.S. Food and Drug Administration clearance of its Access NT-proBNP (N-terminal Pro B-type Natriuretic Peptide) assay for the assessment of heart failure in less than 11 minutes on the Beckman Coulter DxI 9000 Immunoassay Analyzer*. The Access NT-proBNP assay aids in diagnosing patients suspected of having acute heart failure in emergency departments as well as assessing the severity and risk stratification of patients with heart failure and acute coronary syndrome.

The award-winning DxI 9000 Immunoassay Analyzer sets a new standard for today’s busy labs addressing today’s speed, reliability, reproducibility, quality, and menu expansion demands.

According to the Heart Failure Society of America, nearly 6.5 million Americans over the age of 20 have heart failure, accounting for approximately 8.5% of all heart disease deaths in the United States. Beckman Coulter's Access NT-proBNP assay measures concentrations of N-terminal pro B-type natriuretic peptide in serum or plasma that originates in a person's heart. High levels of natriuretic peptides can indicate heart failure.

As recommended in the latest heart failure guidelines from the American College of Cardiology and the American Heart Association, the Access NT-proBNP assay provides age-based cutoffs for diagnosis of heart failure to ensure results are evaluated in the appropriate clinical context for each patient. In addition to age, other patient factors such as gender, obesity and kidney failure can affect natriuretic peptide levels. The Access NT-proBNP assay provides clinical performance information for these subsets of patients to assist clinicians' sample data interpretation and diagnoses.

"We continue to be excited by the quality, sensitivity and specificity of the assays being developed for DxI 9000 Analyzer," Kathleen Orland, Senior Vice President, General Manager, Chemistry, and Immunoassay for Beckman Coulter. "FDA clearance of the Access NT-proBNP assay is just the latest confirmation of the platform's capability to develop ever increasingly more sensitive and clinically relevant diagnostics. The combination of DxI 9000 Analyzer's expanding menu of assays and its operational excellence, highlighted by ZeroDaily Maintenance, PrecisionVision Technology, and IntelliServe is driving laboratory demand around the globe."

About Beckman Coulter. Inc.

A global leader in advanced diagnostics, Beckman Coulter has challenged convention to elevate the diagnostic laboratory's role in improving patient health for more than 80 years. Our mission is to Relentlessly Reimagine Healthcare, One Diagnosis at a Time – and we do this by applying the power of science, technology and the passion and creativity of our teams. Our diagnostic solutions are used in complex clinical testing, and are found in hospitals, reference laboratories and physician office settings around the globe. We exist to deliver smarter, faster diagnostic solutions that move the needle forward from what's now to what's next. We seek to accelerate care with an extensive clinical menu, scalable lab automation technologies, insightful clinical informatics, and optimize lab performance services. Headquartered in Brea, Calif., with more than 11,000 global team members, Beckman Coulter Diagnostics is proud to be part of Danaher. Danaher is a global science and technology leader. Together we combine our capabilities to accelerate the real-life impact of tomorrow's science and technology to improve human health.

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*Full name DxI 9000 Access Immunoassay Analyzer

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