Beckman Coulter, a clinical diagnostics company of Danaher Corporation, has received the US Food and Drug Administration approval for its new heart failure assay, Access NT-proBNP.
The Access NT-proBNP (N-terminal Pro B-type Natriuretic Peptide) assay is designed to run on the company’s DxI 9000 Immunoassay Analyser and detects heart failure within 11 minutes.
It measures concentrations of N-terminal pro B-type natriuretic peptides in serum or plasma, where high levels of natriuretic peptides indicate heart failure.
The assay helps diagnose patients suspected of acute heart failure in emergency departments and assess the severity and risk levels of patients with heart failure and coronary syndrome.
Beckman Coulter chemistry and immunoassay senior vice president, general manager Kathleen Orland said: “We continue to be excited by the quality, sensitivity and specificity of the assays being developed for DxI 9000 Analyser.
“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.”
Beckman Coulter said that its Access NT-proBNP works as recommended in the latest heart failure guidelines from the American College of Cardiology and the American Heart Association.
The assay provides age-based cutoffs for diagnosis of heart failure and provides test results evaluated in the appropriate clinical context for each patient.
In addition to age, Access NT-proBNP also considers other patient factors such as gender, obesity and kidney failure, which can affect natriuretic peptide levels.
The new heart failure assay provides clinical performance information for the subsets, to support the sample data interpretation and diagnoses by clinicians.
