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Regulatory Approved Software for Mutation Analysis in Cancer

Periodic Reporting for period 1 - RASMAC (Regulatory Approved Software for Mutation Analysis in Cancer)

Período documentado: 2019-08-01 hasta 2020-01-31

Cancer is a serious global problem in terms of disease burden and economic costs. As the incidence and prevalence of cancer increases worldwide, advanced cancer drugs have become one of the key cost weights in healthcare budgets. This is a major socio-economical challenge for the EU and global decision-makers. Today, the most promising and expensive anti-cancer therapies (e.g. immunotherapies) rely on mutation analysis of cancer DNA sequencing data. However, state-of-the-art software solutions used to analyse this data lack diagnostic precision and regulatory approvals in the European Union. Oncodia aims to address this apparent market gap.
The overall objective of this project was to develop and optimize a business plan that will guide the development and commercialization of RASMAC - the first CE/IVD- certified commercial software as a medical device (SaMD) for cancer precision diagnostics.
Oncodia performed the feasibility study which will guide the development, clinical validation and commercialisation of RASMAC. The study has provided a valuable understanding of the targeted users, market opportunities, competitive landscape, and regulatory pathways. The clinical evaluation plan has also been developed. As part of this project, the potential partners willing to participate in clinical validation studies have been identified and their commitment to evaluate RASMAC has been secured.
The feasibility study has confirmed a significant business opportunity within the European and global precision diagnostic oncology market.
This feasibility study has further confirmed the innovative character of RASMAC. According to the KOL’s presented with the benchmarking material, our medical device will make it possible to accurately identify cancer mutations in DNA sequencing data and as a result, will increase the precision needed for the right therapy choice. RASMAC will alleviate the pain of the oncologists to control the therapy costs by helping them treat cancer patients with better-personalized medicine.
We strive to develop our product further and to harness the full potential of a medical device software enabling data-driven precision diagnostic oncology. Cancer is a serious global health problem and Oncodia is convinced its innovative medical device will have a significant impact on the cancer burden in Europe and worldwide.
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