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First patient enrolled in Elypta trial

Francesco Gatto

Elypta has enrolled the first patient in the multi-center AURORAX-087A (AUR87A) study involving its novel liquid biopsy platform.

This was achieved at the department of Urology, Norfolk and Norwich University Hospital, UK. Involving 16 hospitals across the EU and US, AUR87A is the largest ever prospective multi-center diagnostic test study for the detection of recurrence after surgery in clear cell renal cell carcinoma (ccRCC), the most common form of kidney cancer.

Elypta’s liquid biopsy is anticipated to detect tumor progression more rapidly than imaging: an earlier detection has the possibility to save or prolong the lives of those suffering a recurrence.

“Currently, there are no clinically applied blood and/or urine-based markers for kidney cancer surveillance and there is a real need for more precise and frequent follow-up methods after curative intent surgery. AUR87A is the first ever prospective multicenter diagnostic test study (level of evidence 1B) to evaluate such a method for postoperative surveillance of patients with ccRCC,” says Dr. Saeed Dabestani, MD PhD, Urologist and Chief Principal Investigator for the AUR87A study.

Has the potential to be used in the diagnosis or monitoring of a range of cancers

Elypta’s liquid biopsy platform quantifies blood and urine-based metabolic glycosaminoglycan (GAG) markers and then uses cloud-based software to compute a cancer-specific score. The platform has the potential to be used in the diagnosis or monitoring of a range of cancers, of which ccRCC is the first cancer type to be evaluated.

“The study design is robust, having been discussed with the US Food and Drug Administration (FDA), and is of the highest quality (clinically, being equivalent to a drug-based phase III randomised controlled trial (RCT)). AUR87A is potentially guidelines-changing in terms of how patients with ccRCC should be surveilled after curative surgery for localized disease,” adds Dr. Dabestani.

The study is being financed by EU program Horizon 2020 SME instrument phase 2 grant of approximately SEK 24 million (2.35 mEuro).

Photo of Francesco Gatto: Co-founder and CSO of Elypta