Swedish molecular diagnostics company Elypta has successfully completed patient follow-up in its landmark international study, AURORAX-0087A (AUR87A). This marks a critical step forward in improving the detection and management of kidney cancer recurrence.
Initiated in 2020 and conducted across 29 hospitals in the UK, EU, USA, and Canada, the AUR87A study has screened almost 1000 patients, enrolling approximately 280 of them across two cohorts. The patients were then followed up for a maximum of 18 months following surgery. AUR87A was designed as a prospective observational in vitro diagnostic (IVD) test study in clear cell renal cell carcinoma (ccRCC), the most common form of kidney cancer.
Earlier this year, promising results from the first cohort of AUR87A were presented at a Plenary Game Changer Session at the2025 European Association of Urology Congress. Today’s announcement confirms the completion of AUR87A’s second cohort and the end of active follow-up; Elypta will use data from Cohort 2 to validate the potential of GAG-based tests to be used in the management of post-surgery RCC patient surveillance.
“Last patient last visit is an important milestone, and one that we could not have reached without the long-standing support and hard work of the study’s Principal Investigators, their clinical centre teams, and the hundreds of patients who consented to AUR87A. We now eagerly look forward to seeing the study results,” says Marianna Mirabelli, Elypta’s Director of Clinical Development and AUR87A Project Lead.
"This is an important step in the external validation of the GAG score as a biomarker for recurrence monitoring in clear cell renal cell carcinoma. This phase of the study is essential to confirm the initial findings from AUR87A Cohort 1 under broader clinical conditions. I would like to thank all participating sites for their steady commitment to reaching this stage. With follow-up completed, we now have the necessary foundation to carry out a thorough analysis of the data in the coming months,” says Saeed Dabestani, AUR87A Chief Principal Investigator, and Associate Professor at Lund University, Sweden
AUR87A primary results are expected later this year.
About AUR87A
AUR87A is a prospective multi-center observational in vitro diagnostics clinical performance evaluation cohort study to validate the diagnostic performance of GAG profiles(GAGome)-based tests for the early detection of recurrence after curative intent surgery in patients at high or intermediate risk of clear cell Renal Cell Carcinoma (ccRCC), the most common form of kidney cancer. Elypta’s GAGome test is currently for research use only.
The study is registered atwww.clinicaltrials.gov, where more information is available (https://clinicaltrials.gov/ct2/show/NCT04006405).The study is co-funded by the European Union’s Horizon 2020 research and innovation program under grant agreement No 849251.
About Elypta
Elypta is a Swedish cancer diagnostic company focused on reducing cancer mortality by enabling earlier detection and closer monitoring. The metabolism-based liquid biopsy platform measures a novel panel of glycosaminoglycan biomarkers (GAGome) and algorithms trained to detect cancer-specific signatures. Elypta is advancing a broad study program across different cancers with the leading indication being early detection of recurrence in renal cell carcinoma. www.elypta.com
