Scoli-Pro®: Kit para el diagnóstico y pronóstico de la Escoliosis Idiopática

The ScoliPro® prototype kit has been designed incorporating our discovered and patented epigenetic biomarkers. The European Society for the Spine (EuroSpine, Austria) funded the initial discovery project in 2012. Patients were firstly analysed using Next Generation Sequencing (NGS) Technology and circulating miRNAs were identified as biomarker candidates.

Our technology has been tested and clinically validated by means of a small-scale clinical trial in two independent cohorts (first cohort 43 subjects, and second cohort 40 subjects), demonstrating a high capacity to discriminate patients from healthy subjects. These results were published in the scientific journal Scientific Reports (Nature), in February 2018. [1] ScoliPro® kit prototype is based on the method and kit patented for the detection of 4 miRNAs by means of RT-qPCR technology using specific primers and probes. This prototype manufacture is being produced and tested in a relevant laboratory environment using blood samples provided by CIBER biobank, to ensure the quality of the process in the context of NEOTEC project, based on I+D+i for product and services supported by “Centro de Desarrollo Tecnológico e Industrial (CDTI)” of the Spanish Ministry of Economy, Industry and Competitiveness started in 2017. Moreover, we are currently validating ScoliPro® in a clinical performance test using independent cohorts of patients from Hospital Universitari I Politècnica la Fe (Valencia), Hospital Gregorio Marañón (Madrid), Hospital Niño Jesús (Madrid), Hospital Sant Joan de Deu (Barcelona) y Hospital Reina Sofía (Sevilla). With this IVD performance trial we accomplish the issues required for obtaining CE-IVD mark and initiate the commercialization of the kit. In addition, a viability plan was elaborated attending to economic factors in terms of market, production costs, sale costs and royalties obtained from commercial agreements with international distributors.

[1] García-Giménez JL, Rubio-Belmar PA, Peiró-Chova L, et al. Circulating miRNAs as diagnostic biomarkers for adolescent idiopathic scoliosis. Scientific Reports. 2018;8:2646. doi:10.1038/s41598-018-21146-x.