Urine biomarker improved five-year cancer risk prediction in 5,436 adults

Pre-specified high-risk group held 54% of cancers over five year - effect strongest for cancers with no screening

Solna, Sweden, November 11, 2026 – Elypta, the Swedish diagnostic company focused on cancer risk, today announced the publication of a peer-reviewed study in Cancer Epidemiology, Biomarkers & Prevention (https://doi.org/10.1158/1055-9965.EPI-26-1059). In 5,436 healthy adults, a profile of urinary glycosaminoglycans (GAGs), long sugar chains that are involved in cancer-related processes, was linked to the risk of a cancer diagnosis within five years, independently of established risk factors.

When the GAG score was combined with risk factors such as age and smoking history, a pre-specified high-risk group, an estimated 13–23% of participants depending on the cohort, accounted for 54% of the cancers diagnosed during follow-up, including 54% of in situ carcinomas. About 17% of participants who stayed cancer-free were also placed in this group. The link to cancer risk was similar across stages and at least as strong in adults under 50 as in older adults. The signal was strongest for several cancers without population screening today, including pancreatic, kidney and brain cancer and lymphoma.

“Today we choose who to screen largely by age and smoking history. This peer-reviewed study shows that a biological signal measured in urine adds independent information about who is at higher risk of cancer, including at the earliest stages,” said Karl Bergman, CEO of Elypta. “It uses just three GAGs, so we see it as a proof of concept for our cancer risk program, which builds on broader GAG panels and also on plasma samples.”

Cancer screening programs today select people mainly by static factors such as age, sex and smoking history. A dynamic biological marker that reflects current changes in tissue could help direct screening to those most likely to benefit, and could support multi-cancer early detection tests, which are expected to work best in people at elevated risk.

“The association was independent of established risk factors and consistent across cancer stages, which makes this dynamic biological marker worth testing prospectively,” said John Field, Professor of Molecular Oncology at the University of Liverpool, a co-author of the study.

The study followed healthy adults from the Lifelines population cohort in the Netherlands. Researchers analysed 24-hour urine from all 827 people diagnosed with cancer within five years and from a random sample of 4,609 who were not; results were scaled to estimate risk in a cohort of 124,436 adults. Researchers from Lund University, the University of Liverpool, Dana-Farber Cancer Institute and Elypta measured three chondroitin sulfate disaccharides by mass spectrometry and built a risk score, alone and combined with 13 established risk factors. Elypta sponsored the study.

The study was retrospective and included mainly people of European ancestry, and independent, prospective validation is needed before any clinical use. Elypta is extending the work to broader panels of up to 11 GAGs and to plasma and plans validation in additional cohorts. The GAGome risk score is a research tool and is not available for clinical use.

For researchers

The MIRAM® GAGome Kit for quantification of urine CS disaccharides (FRUOU-CS) by UHPLC-MS/MS, builds on the analytical method used in this study, and supports exploratory and translational research across disease areas. It is manufactured under Elypta's ISO 13485:2016-certified quality system. For Research Use Only. Not for use in diagnostic procedures. See also Study supplement note: Measuring Range of FRUOU-CS in general population urine

About the study

The study was pre-registered as Sub-Study 1 of LEVANTIS-0087A (ClinicalTrials.gov NCT05235009). Cancer diagnoses were confirmed through the Dutch Cancer Registry. Key figures: each standard deviation increase in the score (10 points) was associated with a 66% higher hazard of cancer (hazard ratio 1.66; 95% confidence interval 1.60–1.73); the corrected C-index, the time-to-event version of the area under the curve (AUC), was 0.69 for the score alone and 0.75 combined with established risk factors; observed five-year cancer risk ranged from 0.18% in the lowest-risk group to 7.6% in the high-risk group and 32% in the very-high-risk group. Gatto F, Davies MPA, Dabestani S, Field JK, O'Donnell EK. Multi-cancer risk prediction in asymptomatic adults using urinary glycosaminoglycan profiling. Cancer Epidemiol Biomarkers Prev. 2026. doi:10.1158/1055-9965.EPI-26-1059

About Elypta

Elypta is a Swedish diagnostic company focused on developing new biomarkers for cancer risk-stratification. The company pursues profiling of glycosaminoglycans (GAGome) as a new category of dynamic biofluid risk markers with the aim to enable an expansion of cancer screening and prevention. Elypta’s leading indication is lung cancer risk with a broader program targeting multi-cancer risk applications. Elypta also serves the glycosaminoglycan research community with standardized GAGome quantification kits for research use.

Contact: Karl Bergman, CEO, karl.bergman@elypta.com

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