Beckman Coulter Receives FDA Clearance for Rapid Heart Failure Test

Beckman Coulter, a leading clinical diagnostics company, announced the U.S. Food and Drug Administration (FDA) clearance of its Access NT-proBNP assay. This new test aids in diagnosing heart failure and assessing its severity in just under 11 minutes on the DxI 9000 Immunoassay Analyzer.

Faster Diagnosis for Improved Patient Care

The Access NT-proBNP assay is particularly valuable in emergency departments for rapidly evaluating suspected heart failure cases. Additionally, it helps assess the seriousness of the condition and potential risks for patients already diagnosed with heart failure or acute coronary syndrome.

This rapid test is crucial considering the significant burden of heart failure in the United States. According to the Heart Failure Society of America, over 6.5 million Americans above 20 have heart failure, and it’s a leading cause of death related to heart disease.

How the Test Works

The Access NT-proBNP assay measures levels of a specific peptide (N-terminal pro B-type natriuretic peptide) in the blood. Elevated levels of this peptide indicate heart failure.

The assay adheres to the latest heart failure guidelines set by the American College of Cardiology and the American Heart Association. It provides age-specific thresholds for diagnosis, ensuring accurate interpretation of results based on each patient’s age. Other factors like gender, weight, and kidney function can also affect these peptide levels. The assay offers clinical performance data for such patient subsets, empowering clinicians for better diagnosis.

Benefits of the DxI 9000 Immunoassay Analyzer

“We are impressed by the quality, precision, and accuracy of the assays designed for the DxI 9000 Analyzer,” said Kathleen Orland, a Senior Vice President at Beckman Coulter.

The FDA clearance of the Access NT-proBNP assay reinforces the DxI 9000’s ability to deliver increasingly sensitive and clinically relevant diagnostics. This platform offers a growing menu of assays along with operational advantages like minimal daily maintenance, precise vision technology, and intelligent data management, making it highly sought-after by laboratories worldwide.

About Beckman Coulter

Beckman Coulter, a global leader in advanced diagnostics, has been a leading innovator in improving patient care through advanced diagnostics for over 80 years. Their mission is to constantly redefine healthcare through better diagnoses, one patient at a time. Their diagnostic solutions are used in various clinical settings worldwide, including hospitals, reference labs, and physician offices. They strive to deliver faster, more intelligent diagnostic tools to advance healthcare. Beckman Coulter is headquartered in Brea, California, with a global team exceeding 11,000 employees. They are a proud part of Danaher, a global leader in science and technology. Together, they aim to leverage their expertise to accelerate scientific and technological advancements for the betterment of human health.