FDA Approval: Beckman Coulter's Heart Failure Assay Now Available on DxI 9000 Immunoassay Analyzer

Thursday, May 30, 2024

Beckman Coulter, a leading name in clinical diagnostics, has recently gained approval from the U.S. Food and Drug Administration for its Access NT-proBNP (N-terminal Pro B-type Natriuretic Peptide) assay.

This advancement enables the swift assessment of heart failure in under 11 minutes using the Beckman Coulter DxI 9000 Immunoassay Analyzer*. The Access NT-proBNP assay is instrumental in diagnosing patients suspected of acute heart failure in emergency settings and in evaluating the severity and risk stratification of individuals with heart failure and acute coronary syndrome.

Heart failure poses a significant health challenge, impacting nearly 6.5 million Americans aged 20 and above and contributing to approximately 8.5% of all heart disease-related deaths in the United States.

Beckman Coulter's Access NT-proBNP assay detects N-terminal pro B-type natriuretic peptide concentrations in serum or plasma, originating from the heart. Elevated levels of these peptides can serve as indicators of heart failure.

Aligned with the latest guidelines from the American College of Cardiology and the American Heart Association, the Access NT-proBNP assay offers age-based cutoffs for heart failure diagnosis, ensuring that results are interpreted within the appropriate clinical context for each patient.

Additionally, factors such as gender, obesity, and kidney failure can influence natriuretic peptide levels. The Access NT-proBNP assay provides clinicians with performance data for these patient subsets, facilitating accurate data interpretation and diagnoses.

Senior Vice President and General Manager of Chemistry and Immunoassay at Beckman Coulter, expressed enthusiasm for the assay's quality, sensitivity, and specificity.

Highlighted the FDA clearance as evidence of the platform's capability to develop increasingly sensitive and clinically relevant diagnostics.

The combination of the DxI 9000 Analyzer's expanding range of assays and its operational excellence, featuring ZeroDaily Maintenance, PrecisionVision Technology, and IntelliServe, is driving global demand for laboratory services.


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