Osteoarthritis (OA) is the most common aging related joint disease among the elderly population and one of the ten most disabling diseases in the developed world. It is characterised by progressive degeneration of the articular cartilage. According to the WHO, 9.6% of men and 18% of women worldwide aged over 65 years are affected by OA and 25% of them cannot perform their major daily activity, and consequently suffer of depression and isolation. Other risk factors for OA include obesity, previous joint injury, overuse of the joint, weak thigh muscles, and genetics. No cure for this disease is currently available, and existing treatments are either symptomatic (physical therapy, anti-inflammatory and analgesic drugs) or highly invasive (partial or total joint replacement). Moreover, big pharmaceuticals companies have lately moved away from the osteoarthritis field as many drugs failed in development because of a large heterogeneity in the patient population.
In response, the BIOFOSTE team, composed by the SMEs IRTAL and Cyanagen, has developed a strategy for, an early diagnosis, which enables conservative, improving or preventive treatments to contain the advancement of the disease, thus relieving the major economic and social burden represented by OA. They aim to fulfil the OA medical need by clinically validating an innovative panel of biochemical markers correlated with OA progression that can accurately identify early pre-symptomatic OA. Interviews with Key Opinion Leaders (KOLs) have confirmed interest from the field, but have confirmed the need for clinical validation.
The selection and validation of the markers will be performed via clinical trials and the validated panel of biomarkers will be integrated by Cyanagen into a highly-sensitive ELISA kit, based on Cyanagen’s patented chemiluminescent technology. The combined effort of IRTAL and Cyanagen will result in the development of an easy-to-use, non-invasive and highly specific ELISA kit. In order to provide an early payback investment and to ease the adoption of the kit as a support decision tool for clinicians, it will be first launched to the market as a Research Use Only kit. After validation via clinical trials and CE marking certification, the kit will be distributed as an In Vitro Diagnostic (IVD) medical device and could enter the OA clinical workflow as a standard decision support tool. In the best-case scenario, we expect to sell 150000 kits/year in the EU and US at an average price of €3,178 5 years after launch, with revenues over €130M and profits over €25M realising a return of investment already 2 years after launch. In the long term, society will benefit from reduced healthcare costs, by delayed or absence of replacement surgery, the reduced need for medication, and the overall longer employability of patients.
