Former cancer patients receive regular follow-ups to detect recurrences at early stages and optimize treatment outcomes. The follow-up frequency is currently limited by costs and radiation risks of imaging approaches used to surveil for recurrences, resulting in recurrences being detected too late– often resulting in terminal disease. Of the 139.000 annual Renal Cell Carcinoma (RCC) patients,20% are diagnosed with a metastatic recurrence within 5 years after surgery. Once metastatic, RCC survival rates drop to 12% over 5 years survival. Elypta, Sweden, has developed the first metabolism based liquid biopsy to detect early-stage recurrences. The quantification of a metabolite signature in blood or urine and an algorithmic analysis allows for exceptional sensitivity, a low cost of the platform and significantly improves on imaging approaches in cost and risk, enabling frequent patient follow-up. Elypta’s technology has been demonstrated in small clinical trials and its cost effectiveness assessed by two independent companies. Elypta’s platform is easily scalable to other cancer indications and applications such as treatment monitoring, as demonstrated in multiple small trials. Starting in the niche RCC market with limited competition, Elypta now requires clinical evidence for a product launch within RCC. The business strategy focuses on distribution and sales through clinical laboratories, which will benefit financially off sales. As users of the platform, oncologist and urologists have all signed letters of support. A pharmaceutical partner has also signed a letter of support, expressing their interest in RUO use of the platform, providing a solid basis in the emerging liquid biopsy market (€200B market). In AURORAX, Elypta set out to 1) perform a clinical validation trial (AUR87A) to generate strong clinical evidence, 2) submit for regulatory clearance in the EU and the US and 3) introduce the product for research use only (RUO) and after clinical validation enter the RCC diagnostics market in EU. The project has been concluded with successful progress on all three objectives: AUR87A was launched in 2019, successfully completed recruitment in 2021 despite the challenges imposed by the COVID-19 pandemic in global clinical research efforts and generated the first evidence of clinical data in 2022; the regulatory submission process has been successfully started in 2022; and an RUO product has been marketed since 2020.
