Stockholm, Dec 08, 2021: Elypta announces the enrollment of the first patient in the newly initiated AURORAX-0093A (AUR93A) study. AUR93A is intended to explore Elypta’s metabolism-based liquid biopsy platform for the prognosis of muscle-invasive bladder cancer (MIBC) before neo-adjuvant chemotherapy. The first patient was enrolled at San Raffaele Hospital, Milan, Italy.
The standard treatment for MIBC is neo-adjuvant chemotherapy followed by radical cystectomy. However, 70% of patients do not respond to neo-adjuvant chemotherapy. In AUR93A, Elypta is exploring the prognostic performance of its liquid biopsy platform, which is based on novel non-invasive biomarkers of cancer metabolism – the profile of urine and plasma glycosaminoglycans or GAGomes. In a collaboration between Elypta, MediTeq and Lund University, AUR93A is part of a project co-funded by the Swedish Innovation Agency (VINNOVA) aimed at executing all pre-marketing activities for the new test for MIBC prognosis using Elypta’s liquid biopsy platform. This test will enable urologists to better discern patients with poor versus favorable prognosis.
"About two thirds of patients with muscle invasive bladder cancer will not respond to the standard of care neo-adjuvant chemotherapy prior to radical cystectomy. Better tools for determining which patients potentially would benefit from neo-adjuvant chemotherapy is therefore of great importance as it reduces overtreatment of patients while also allowing for a more cost-efficient health care. In this context, we are with the AUR93A study hoping to show GAGome measurement prior to neo-adjuvant chemotherapy to be such a tool,” says Dr. Saeed Dabestani, MD PhD, Urologist, Researcher and acting end-user consultant for the AUR93A study.
AUR93A recruitment is ongoing and the study is slated for completion in 2023.
Karl Bergman, CEO, karl.bergman@elypta.com Tel: +46 73 262 53 33.
AURORAX-0093A (AUR93A) is a prospective observational in vitro diagnostics clinical development cohort study to develop free GAGome-based tests for the prognosis of muscle-invasive bladder cancer patients elected for neo-adjuvant chemotherapy before radical cystectomy.
The study is registered at www.clinicaltrials.gov where more information is available (https://clinicaltrials.gov/ct2/show/NCT05028660). The study is co-funded by the strategic innovation programs of Swelife and Medtech4Health, a joint venture by Vinnova, Formas and the Swedish Energy Agency.
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. www.elypta.com.
