Diagnostic biomarker discovery study in metastatic ccRCC, showed coordinated regulation of GAG biosynthesis
GAGome alterations correlated with survival in metastatic ccRCC providing prognostic biomarker proof-of-concept
Alterations from normal levels in early-stage RCC provides diagnostic biomarker proof-of-concept
Established the analytical performance of the 1st gen GAGome kit
First baseline study in a general population on a standardized GAGome kit
First prospective single-center study providing proof-of-concept for GAGome as monitoring biomarkers in RCC
First proof-of-concept study demonstrating early stage sensitivity to 14 cancer types in an asymptomatic population
First prospective single-center study providing proof-of-concept for GAGome as response monitoring biomarkers in RCC
Proof-of-concept study on GAGome scores as biomarkers to differentiate between MPS subtypes
Describes the development approach behind the first high-hroughput and standardized GAGome kit
Retrospective validation study on GAGome as risk-stratification markers in bladder cancer
Proof-of-concept study developing a plasma-based lung-cancer score showing elevated early-stage sensitivity compared with cfDNA
Retrospective validation of a plasma-based lung cancer GAGome score to improve on LLPv3 risk model in a symptomatic population
Proof-of-concept study on GAGome as multi-cancer risk stratification biomarkers on a 5-year time horizon before diagnosis
Multi-center international development study in ccRCC recurrence surveillance (AUR87A Cohort 1)
The 3rd generation GAGome kits will measure the protein-free fraction of 11 or more CS, HS & HA GAG disaccharides with quality and precision required to support translational research. The kit will come in versions varying in analyte scope & matrices and are optimized to run on the new Waters® Acquity I-class Plus Xevo TQ Absolute XR (or similar performance mass spectrometers), enabling over 100x Lower Limit of Quantification versus previous generations.
Commercial release targeted in 2027.
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ISO 13485:2016 certified for Design, development and manufacture of in vitro diagnostic test kits and software for the measurement and interpretation of glycosaminoglycans (GAGs) in human biofluids
