MetaMedical™ Solutions Inc

US FDA approves Beckman Coulter’s assay to assess heart failure

The NT-proBNP assay is designed for use on the DxI 9000 Access Immunoassay Analyzer. Credit: PRNewswire / Beckman Coulter Diagnostics.

The US Food and Drug Administration (FDA) has approved clinical diagnostics company Beckman Coulter’s rapid heart failure assay, Access N-terminal Pro B-type Natriuretic Peptide (NT-proBNP) assay.

Designed for the DxI 9000 Access Immunoassay Analyzer, the Access NT-proBNP assay can detect heart failure biomarkers in under 11 minutes.

It is a significant advancement for the rapid diagnosis of patients suspected of having acute heart failure, particularly in emergency department settings.

The assay also helps assess the severity and risk stratification of individuals with acute coronary syndrome.

This diagnostic tool measures concentrations of the N-terminal pro B-type natriuretic peptide in a patient’s serum or plasma. Elevated levels of this peptide are indicative of heart failure.

Beckman said the assay adheres to the latest heart failure guidelines from the American College of Cardiology and the American Heart Association, which recommend age-based cutoffs for heart failure diagnosis.

Access the most comprehensive Company Profiles
on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free
sample

Your download email will arrive shortly

We are confident about the
unique
quality of our Company Profiles. However, we want you to make the most
beneficial
decision for your business, so we offer a free sample that you can download by
submitting the below form

By GlobalData







Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

This ensures that patient results are evaluated within the context of clinically relevant parameters, including age, disease comorbidity data, and gender.

Beckman Coulter Chemistry, and Immunoassay general manager and senior vice-president Kathleen Orland said: “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.” 

Factors such as gender, obesity, and kidney failure can influence natriuretic peptide levels. Beckman Coulter’s assay accounts for these variables, providing clinicians with performance data that aids in the interpretation of patient samples and supports accurate diagnoses.


Source link