Stockholm, Dec 15, 2021: Swedish molecular diagnostics company Elypta announces today the activation of the 26th recruiting site for the AURORAX-0087A (AUR87A) study, making it the largest diagnostics study ever of the most common type of kidney cancer. AUR87A is intended to validate Elypta’s metabolism-based liquid biopsy platform for the detection of recurrence after surgery in clear cell renal cell carcinoma (ccRCC).
About 1 in 5 ccRCC patients experience recurrence within 5 years after surgery for confirmed disease. Since there is no liquid biomarker yet approved for ccRCC recurrence, current follow-up is still based on medical imaging and remains sub-optimal.
AUR87A opened in January 2020 in 16 sites across 6 countries in Europe and the US. With the present expansion, another 10 sites were added to the study, which is now recruiting patients from 10 different countries.
“We are thrilled and honored to have the support and engagement from such a distinguished panel of kidney cancer urologists. The commitment of all investigators across the 26 sites and their teams are a testament to the significance of this truly unique study” says Marianna Mirabelli, Director of Clinical Development at Elypta.
“The addition of clinical sites to facilitate the expansion of the AUR87A trial highlights the enthusiasm clinicians have towards biomarkers in cancer surveillance in kidney cancer. We hope for a fruitful partnership with these institutions and welcome their contribution to an important study!” says Dr Rajesh Nair, Consultant Urological Surgeon at Guy’s and St Thomas’ NHS Foundation Trust and UK Lead for AUR87A.
The liquid biopsy platform developed by Elypta relies on novel non-invasive biomarkers of ccRCC metabolism – the profile of urine and plasma glycosaminoglycans or GAGomes. Elypta developed machine learning algorithms to transform changes in the GAGomes into a so-called GAG score that correlates with the presence of ccRCC.
“AUR87A represents a great opportunity to introduce an innovative approach to cancer recurrence diagnostics and a way to address a current unmet need with a precise and cost-effective tool for a more optimised follow-up,” says Dr. Saeed Dabestani, MD PhD, Urologist and Chief Principal Investigator for the AUR87A study.
As of today, AUR87A has screened more than 400 patients, enrolling more than 130. The recruitment period is currently slated for completion in June 2022.
Karl Bergman, CEO, karl.bergman@elypta.com Tel: +46 73 262 53 33.
AURORAX-0087A (AUR87A) is a prospective multi-center observational in vitro diagnostics clinical validation cohort study to validate the diagnostic performance of free GAGome-based tests for the early detection of recurrence after curative intent surgery in patients with high or intermediate risk ccRCC.
The study is registered at www.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.
Elypta is a Swedish molecular diagnostics company focused on reducing cancer mortality by enabling earlier detection and closer monitoring. The metabolism-based liquid biopsy platform in development measures a novel panel of biomarkers and utilizes machine learning algorithms to generate cancer-type specific GAG scores. Elypta is advancing a broad study program across different cancers with the first indication expected to be early detection of recurrence in renal cell carcinoma.
