Cohort 2 aimed at prespecified independent validation of the ccRCC recurrence test configuration described below. Sensitivity was 77.4%, specificity was 26.8%, and the odds ratio was 1.25 (one-sided p = 0.318). The 90% sensitivity and 97% negative predictive value below remain the results observed in Cohort 1 but were not confirmed. The suggestion that a urine sample could replace repeated radiological exams was an inference from Cohort 1 and is not supported by the current evidence from Cohort 2: AUR87A Cohort 2 results
Scope of the findings
These findings apply only to the locked algorithm and cutoff evaluated in AUR87A Cohort 2 for recurrence in non-metastatic clear cell renal cell carcinoma, where that configuration did not show the required clinical performance. The study does not establish or refute the performance of other glycosaminoglycan (GAG) based algorithms, test configurations, sample types or cancer indications, each of which will require its own validation. The locked Cohort 2 configuration was based on three chondroitin sulfate disaccharides as analytical inputs, whereas earlier GAG test configurations used a broader 17-analyte panel. Elypta's other GAG programmes continue on their own development and validation paths unaffected by these results.
Elypta, the Swedish company pioneering metabolism-based cancer diagnostics, is proud to announce that findings from the internationalAURORAX-0087A (AUR87A) study, the largest diagnostics study ever conducted on the most common type of kidney cancer, were presented today in a PlenaryGame Changer Session at the 2025 European Association of Urology Congress.
The AUR87A study, conducted across 29 hospitals in the UK, EU, USA, and Canada, evaluates the use of glycosaminoglycans (GAGomes) as urine-derived metabolic biomarkers to monitor kidney cancer recurrence in patients following surgery.
The intermediary results show that the test correctly identified 90% of patients with recurrent cancer. Notably, a negative score corresponded to a 97% probability of being recurrence-free.
This high negative predictive value supports Elypta’s belief that post-treatment monitoring of cancer patients needs to be transformed. Instead of undergoing repeated radiological exams – a process that can both expose the patient to radiation and constitute a significant burden – patients could submit a simple urine sample.
“These findings show the potentially transformative impact a urine-based test may have in the surveillance of recurrent disease for kidney cancer patients,” says Karl Bergman, Elypta CEO.
“A urine test can offer a less invasive and more comfortable alternative for post-operative monitoring, potentially transforming kidney cancer follow-up care,” said Volker Liebenberg, Chief Medical Officer at Elypta.
While the test is currently designated for research use only, this encouraging data from the AUR87A study underscores its potential to enhance patient care and streamline clinical protocols.
The study’s second patient cohort is nearing final recruitment, with validation results expected later this year.
About AURORAX-0087A
AURORAX-0087A is a prospective multi-center observational in vitro diagnostics clinical validation cohort study to validate the diagnostic performance of GAGome-based tests for the early detection of recurrence after curative intent surgery in patients with high or intermediate risk of clear cell Renal Cell Carcinoma (ccRCC),the most common form of kidney cancer.
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.
About Elypta
Elypta is a Swedish cancer detection 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 indications being early detection of recurrence in renal cell carcinoma and multi-cancer early detection. www.elypta.com
AboutEAU25
Europe’s biggest urology congress will take place from 21-24 March 2025 in Madrid, Spain. With over 1,700 abstracts presented and moderated live, the 40th Annual Congress of the European Association of Urology (EAU25) will be amongst Europe’s biggest medical congresses in 2025. The packed four-day scientific program includes live surgery, state-of-the-art lectures, case discussions and debates. See the full scientific programme on the congress website: www.eau25.org
