Diagnostics device for rapid testing of prostate cancer at Point-of-care

Información del proyecto

Nevada

Identificador del acuerdo de subvención: 836867

DOI

10.3030/836867

Proyecto cerrado

Fecha de la firma de la CE 30 Noviembre 2018

Fecha de inicio 1 Diciembre 2018

Fecha de finalización 31 Marzo 2019

Financiado con arreglo a

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Coste total

€ 71 429,00

Aportación de la UE

€ 50 000,00

Coordinado por

MDXHEALTH
Belgium

Periodic Reporting for period 1 - Nevada (Diagnostics device for rapid testing of prostate cancer at Point-of-care)

Período documentado: 2018-12-01 hasta 2019-03-31

Resumen del contexto y de los objetivos generales del proyecto

Prostate Cancer (PCa) is the most common cancer among men in Europe. Men are routinely screened for prostate-specific antigen (PSA) in the blood and undergo a digital rectal examination (DRE) to be selected for prostate biopsy that is currently the only method that can confirm PCa. However, up to 80% of positive PSA test results are followed by negative biopsy. We have identified a high unmet medical need for a new diagnostic method that will allow rapid and efficient test to identify rapidly those men that are not at increased risk of PCa and can avoid painful and invasive prostate biopsy. Nevada is based on our clinically validated test that is already on the market and combines the analysis of biomarkers in the urine (“liquid biopsy”) with a software analysis evaluating other risk factors to predict the risk of significant PCa. We aim to further simplify the test to be able to offer it not only in urologist´s clinics, but also by general practitioners (GPs).

Trabajo realizado desde el comienzo del proyecto hasta el final del período abarcado por el informe y los principales resultados hasta la fecha

In phase 1, we have evaluated the technical and financial feasibility to transfer this test into a complete Point of Care (POC) platform and after a thorough analysis we have selected three potential POC platforms manufacturers that fulfill our technical requirements.
Moreover, we have evaluated the technical feasibility of the development on new software analysis to eliminate the need for diagnostic exams performed by a urologist. Preliminary results showed that we can replace a variable, such as the determination of prostate volume with other exams easily performed by GPs while maintaining the high specificity and selectivity of Nevada. We have evaluated the technical risks and proposed mitigation measures. We have concluded that considering our already established network of KOLs and sales team across Europe our project is commercially feasible, and we plan to launch Nevada on the market already in 2022. Our financial evaluation of the project showed that Nevada will be highly profitable.

Avances que van más allá del estado de la técnica e impacto potencial esperado (incluida la repercusión socioeconómica y las implicaciones sociales más amplias del proyecto hasta la fecha)

We will be first to offer a diagnostic test for PCa implemented on a POC platform, therefore eliminating the need of a traditional central laboratory analysis and bringing the diagnostic test closer to the patient. Furthermore, the elimination of diagnostic exams that need to be performed by the urologist will allow us to offer Nevada at GPs practices. With Nevada, we will decrease the number of unnecessary prostate biopsies, increasing the quality of life of the patients and reducing health care costs.

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