Groundbreaking assay development for measuring total NT-proBNP levels

28. Jun 2024 | 5 min read

Press release

Moss, 28 June 2024

At the upcoming Association for Diagnostics & Laboratory Medicine (ADLM) 2024 clinical meeting, to be held in Chicago on 29 July 2024, Gentian Diagnostics ASA will showcase a significant breakthrough in the development of its turbidimetric NT-proBNP assay. The new assay will accurately measure NT-proBNP levels without being affected by glycosylation. This advancement will allow for NT-proBNP analysis on high-throughput clinical chemistry platforms while eliminating the inaccuracies caused by glycosylation.

Gentian’s NT-proBNP assay on high throughput, open channel instruments  
While several NT-proBNP assays already exist on chemiluminescence-based platforms for diagnosing and assessing the severity of heart failure (HF), Gentian aims to make NT-proBNP analysis more accessible on high-volume clinical chemistry analysers. This improvement will enhance both cost and workflow efficiency.

Addressing glycosylation 
Current commercial assays mostly use antibodies that bind to the central region of NT-proBNP, which is typically glycosylated. This glycosylation significantly affects sample readings, as up to 80% of NT-proBNP may be glycosylated in this region. The glycosylation restricts antibody binding and thereby protein detection, leading to underestimation of NT-proBNP levels.

Extensive testing of Gentian’s prototype has confirmed that glycosylation of the NT-proBNP molecule can indeed lead to an underestimation of NT-proBNP concentrations in clinical samples. In contrast, Gentian's NT-proBNP assay is designed to detect endogenous NT-proBNP regardless of glycosylation status, avoiding this common underestimation.

Effect of glycosylation on NT-proBNP measurements 
At ADLM 2024, Gentian will present a poster titled: Development and diagnostic utility of immunoturbidimetric NT-proBNP assay based on antibodies targeting glycosylation-free regions of NT-proBNP (A-010), with a comparison of the Gentian’s assay with another commercially available immunoassay. The results confirm the underestimation of NT-proBNP concentration in clinical samples due to glycosylation effects, which Gentians’ prototype successfully avoids. 

Advantages for heart failure diagnosis and management 
Given the variability in glycosylation pattern of NT-proBNP, an immunoassay targeting glycosylation-free regions may offer significant advantages in heart failure management. This assay will detect endogenous NT-proBNP regardless of glycosylation status, providing more reliable data for specific patient groups and disease states.

About Gentian Diagnostics 
Gentian Diagnostics (OSE: GENT), develops and manufactures high-quality, in vitro diagnostic reagents. Gentian’s expertise and focus lies within homogenous immunoassays, specifically infections, inflammations, kidney failures and congestive heart failures. By converting existing and clinically relevant biomarkers to the most efficient automated, high-throughput analysers, the company contributes to saving costs and protecting life. Gentian is headquartered in Moss, Norway, serving the global human and veterinary diagnostics markets through sales and representative offices in Sweden, USA, and China. For more information, please visit www.gentian.com. 

IR contact: 
Njaal Kind, CEO 
njaal.kind@gentian.no 
+47 919 06 525 (mobile)

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