The solutions developed for Lots 1, 3 and 4 bring major improvements to existing solutions or are completely new and highly innovative solutions. The modular and interoperable solutions can be combined into at least 2 different diagnostic NGS workflows covering all steps from the patient (collection of biological samples) to the patient (reporting of results and support of therapeutic decision making at the bedside). This also allows integration of new solutions into existing workflows, which markedly reduces implementation barriers. In addition, this flexibility opens the opportunity for the innovative SMEs involved to combine their solutions with products from the large market leaders (e.g. sequencing platform providers).
Another major impact of the solutions is expected by integrating cancer gene testing with pharmacogenomics information since this is still not widely implemented in medical routine diagnostics. In this context the integrated reporting of results of cancer-related alterations, pharmacogenomics variants together with information on essential prescription (e.g. e-medication) information will be a substantial improvement to achieve acceptance of innovative technologies by clinicians to support their decision making in daily cancer care. This also better exploits the power of NGS and increases the health economic benefit of NGS-based diagnostics because every patient will experience benefit either by targeted therapy or improved classical therapy including supportive medications. Improvement of the health economic benefit as to be demonstrated by future Health Technology Assessment markedly facilitates reimbursement for NGS-based diagnostics by payers thereby improving market opportunities for the manufacturers and enabling access to innovative diagnostics for patients.
Market opportunities beyond the Buyers group have been opened by a variety of supportive activities including proactive dissemination of results to the >200 leading European cancer hospitals that are members of OECI and the two ERNs that are led by two beneficiaries, presentation to the global network of directors of national cancer institutes, engagement with medical societies, presentation of results at conferences and scientific publication, dissemination in social media and engagement with policy makers in the European parliament. Furthermore, the active participation of patient advocacy groups, development of education and training materials, engagement with regulators and standardization organizations, health economic assessment and engagement with health policy makers and payers is expected to support wide implementation and usage of the solutions developed.
Some of the solutions developed are ready for IVDR conformity assessment whereas others might benefit from further improvement based on feedback from real-word environment testing performed by Buyers in Phase. It is expected that most of the solutions developed within Instand-NGS4P will be placed on the market within the next one to three years.
