Gentian Diagnostics: Study Confirms the Value of Calprotectin in Early Detection of Neonatal Infections and Sepsis

23 Oct 2025 10:15 CEST

Belgrade, October 23, 2025

Gentian Diagnostics ASA, a fast-growing developer and manufacturer of diagnostic
tests, is pleased to announce that results from a collaborative study conducted
with the University Children's Hospital Regensburg (KUNO) and Hospital St.
Hedwig of the Order of St. John (Regensburg, Germany) confirm the value of
calprotectin in the early detection of bacterial infections and sepsis in
neonates. The findings were presented at the Joint European Neonatal Societies
(jENS) Congress in Belgrade.

Early detection of infections - a persistent challenge in neonatal care

Early identification of infection remains one of the greatest challenges in
neonatal medicine. Conventional biomarkers such as C-reactive protein (CRP) and
interleukin-6 (IL-6) are well established, yet each presents limitations in
timing and specificity.

The oral presentation, titled “Serum calprotectin as a routine biochemical
parameter to improve early diagnosis of neonatal infections,” highlighted
calprotectin’s diagnostic accuracy and robustness across the first 60 hours
after symptom onset.

The study demonstrated an early and sustained increase in calprotectin levels in
infants with confirmed infections, detectable within the first 0–18 hours after
symptom onset. IL-6 showed an early increase that declined after 18–30 hours.
CRP levels rose later, typically after 18–30 hours. Calprotectin remained
elevated and stable throughout the 60-hour observation period.

These findings confirm that calprotectin is a promising early biomarker that
provides substantial diagnostic value when combined with IL-6 or CRP, enhancing
diagnostic performance both in the early and later phases of infection.

Clinical implications

Investigators concluded that serum calprotectin, measured with the Gentian GCAL®
assay, supports multimodal diagnostic strategies and antibiotic stewardship. The
assay requires only a minimal sample volume and enables fully automated
laboratory implementation, making it a practical addition to routine clinical
workflows.

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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657780_jENScongress_press release.pdf