Descrizione del progetto
Una piattaforma diagnostica innovativa basata sul metabolismo per il follow-up dei pazienti oncologici
I pazienti oncologici devono sottoporsi a follow-up regolari per rilevare precocemente le recidive e ottimizzare le strategie di trattamento. Spesso, però, con gli attuali approcci di sorveglianza, la rilevazione avviene tardi. L’azienda svedese Elypta ha sviluppato la prima biopsia liquida basata sul metabolismo per rilevare le recidive in fase iniziale. La piattaforma di rilevamento ha dimostrato una sensibilità straordinaria a un costo ridotto, consentendo il follow-up frequente dei pazienti. La tecnologia è stata collaudata in sperimentazioni cliniche su piccola scala. Gli obiettivi del progetto AURORAX, finanziato dall’UE, sono la conduzione di un’ampia sperimentazione clinica di validazione, il conseguimento dell’autorizzazione regolamentare nell’Unione europea e negli Stati Uniti e l’introduzione del prodotto per la ricerca anche nel mercato europeo della diagnostica del carcinoma a cellule renali.
Obiettivo
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. During the AURORAX, Elypta will 1) perform a clinical validation trial (AUR87A) to generate strong clinical evidence, 2) obtain 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. 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).
Campo scientifico
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Invito a presentare proposte
Vedi altri progetti per questo bandoBando secondario
H2020-SMEInst-2018-2020-2
Meccanismo di finanziamento
SME-2 - SME instrument phase 2Coordinatore
111 56 Stockholm
Svezia
L’organizzazione si è definita una PMI (piccola e media impresa) al momento della firma dell’accordo di sovvenzione.