A rapid and cost-effective point-of-care diagnostic kit able to predict treatment response for appropriate multiple sclerosis management
Multiple sclerosis (MS) is the most common chronic inflammatory disease of the central nervous system currently affecting about 2.5 million people worldwide (mainly young adults, three times more women than men). There is no cure and therapies do not properly work in all patients. Personalized medicine is needed but we lack predictive biomarkers for treatment response to secure prompt and early treatment and the best clinical outcomes for each patient. Thus, MS represents a major public health issue with a substantial socioeconomic impact (€15.5 B annual costs in Europe). Bioithas is a biotechnology company in the field of health developing new diagnostic and therapeutic targets for autoimmune and inflammatory diseases. In response to the unmet need, it is focused on developing the first-ever gut microbiota based biomarker for predicting MS treatment response. ScleroTest, a quick point-of-care (PoC) diagnostic tool, will allow immunomodulatory profiling of patients to predict treatment response. It is a non-invasive, accurate (PCR performance), rapid (results in <24 h) and cost-competitive test (€25 test, ca. 58 % cheaper than magnetic resonance and JC virus alternatives). ScleroTest implantation in routine practice will face current MS management problems resulting on added value for patients, neurologists and health systems by allowing fast and correct therapy choice, better clinical outcomes and cost-savings. ScleroTest scalability will also open new avenues for personalized therapy in other diseases. Due to ScleroTest´s cost-competitive features plus the absence of real competition, the increasing MS prevalence and incidence globally and the growing PoC market (CAGR 10%, €33 B by 2022), Bioithas foresees ScleroTest as a fruitful business opportunity (accumulated net profit ca. €18.02 M, 2022-2026). To secure the successful market launch, we will perform a feasibility study analyzing technological, commercial and financial aspects to finalize our business plan.