Groundbreaking assay development for measuring total NT-proBNP levels

28 Jun 2024 11:02 CEST

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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