Project description
Innovative diagnostic method for infertility
Infertility affects 25 million Europeans. Many times, infertility in both men and women is due to genetic disorders. As such, identifying its causes requires genetic testing for approximately 35 % of the couples under diagnosis. However, many factors obstruct the efficiency of infertility genetic analysis and the entire diagnosis process. In this context, the EU-funded One4Two project will create the first integrated system providing an inclusive diagnostic service for infertile couples. From lab analysis to diagnosis, only one blood sample will be needed. The project aims to optimise the system with end-users, to take the necessary steps for the required certifications, upscaling, and commercialisation and to consolidate the business model, marketing strategy and pricing.
Objective
Infertility is a disorder of the reproductive system which affects 25 million citizens in Europe, preventing them from fulfilling their desire to become a parent. To identify its causes, genetic testing is prescribed to around 35% of the couples under diagnosis, since several factors related to infertility have a genetic origin. However, the effectiveness of infertility genetic analysis and the whole diagnosis process are affected by several issues: an uncomprehensive approach to fertility genetic test, with just a handful of genetic diseases being investigated, each through a dedicated test; a fragmented and cumbersome genetic investigation process that negatively impacts on the couple, adding to the psychological distress caused by infertility, with several batteries of tests often in different laboratories, long diagnosis times and high costs; the lack of a specific genetic testing protocol and diagnosis report for infertility, which increases the workload for laboratories and complicates the diagnosis by gynecologists. KronosDNA has developed One4Two, the first integrated system that provides a comprehensive diagnostic service for the infertile couple, able to cover the whole diagnostic path from lab analysis (through a panel of reagents to analyse DNA through Next Generation Sequencing) to the diagnostic report (by means of a proprietary analysis software). One4Two, with just one blood sample, in 5 days and at an affordable price, provides a complete report on the mutations linked to infertility, probability scores for the transmission of inherited diseases, and the most suitable ART therapies to treat infertility. This is poised to reduce analysis workload, simplify diagnosis by the gynecologist and reduce time to pregnancy. During Phase 1 project, the system will be optimized with end-users to prepare the ground for the required certifications, upscaling and commercialization, by also consolidating the business model, the marketing strategy and the pricing.
Fields of science
Programme(s)
Funding Scheme
SME-1 - SME instrument phase 1Coordinator
80133 NAPOLI
Italy
The organization defined itself as SME (small and medium-sized enterprise) at the time the Grant Agreement was signed.