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BIOFOSTE Report Summary

Project ID: 718965

Periodic Reporting for period 1 - BIOFOSTE (Clinical validation of a BIOmarker panel For OSTEoarthritis diagnosis: BIOFOSTE)

Reporting period: 2016-04-01 to 2016-09-30

Summary of the context and overall objectives of the project

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.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The BIOFOSTE team is in the development stage of a new In-Vitro Diagnostic (IVD) kit for early OA detection and progression monitoring based on a highly sensitive, non-invasive chemiluminescent ELISA test for blood serum. The IVD kit will consist of a panel of biochemical biomarkers correlated with OA progression identified/selected by IRTAL and combined with the chemiluminescent technology developed by Cyanagen. During the project, a first selection of the markers for the panel as well as business activities have been performed. An overview of the tasks performed and the results achieved is presented below:
TASK 1: First selection of the Biomarkers for the BIOFOSTE panel by means of a meta-analysis and preliminary FTO. RESULTS: A panel of biomarkers to be validated in the clinical trials has been defined.
TASK 2: Economic feasibility assessment. RESULTS: market analysis for the osteoarthritis diagnostic kit, consideration about the regulatory framework, development of a pricing and commercialisation strategy.
TASK 3: Development of a dissemination strategy for the project results. RESULTS: identification of main stakeholders and development of an effective dissemination strategy to approach and involve them.
TASK 4: FTO analysis and definition of the strategy for intellectual property protection. RESULTS: A sound strategy including IP protection and licensing agreements has been developed.
TASK 5: Partner search. RESULTS: a number of commercialisation and dissemination partners for the project results have been identified. Some collaborations have been already established, in particular with clinical partners in the trials sites, with Biobanks and with potential subcontractors for the Phase II.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

The first clinical manifestation of osteoarthritis (OA) is joint pain, followed by articular stiffness and locomotion restriction. In the presence of typical symptoms and signs in the at-risk age group, OA may be diagnosed without radiography or laboratory investigation. Additional diagnostic tests, such as X-ray, Computed Tomography scanning, Magnetic Resonance Imaging are valuable to estimate the progression stage of the disease or to rule out other forms of arthritis, i.e. rheumatoid and psoriatic arthritis. Nevertheless, these techniques can confirm the diagnosis of OA only when the articular cartilage is significantly degraded, as they lack the sensitivity to detect the signs of disease onset, such as articular cartilage micro injuries. Techniques such as delayed Gadolinium-enhanced MRI and arthroscopy, are not suitable for early OA diagnosis or for population screening due to high costs and limited availability. Several biomarkers have been proposed as alternative diagnostic tools, but none of the IVD immunoassay kits currently on the market are intended for early OA diagnosis.
The current absence from the market of a highly specific diagnostic kit for OA has prompted IRTAL and Cyanagen to seize this business opportunity and bring to the market an in vitro diagnostic tool for early OA detection.
IMPACT: The subjects receiving the main economic benefits from the use of the BIOFOSTE IVD kit will be OA health professionals, patients, and EU National health care systems. Health professionals will be supported during the decision making processes in OA therapy; patients will be treated in the early stage of the disease with a conservative approach, reducing private treatment/assistance costs, caregivers’ costs, and economic losses due to unproductivity, absenteeism, and disability; health care systems will benefit from a reduction of the costs, surgical procedures and hospital length of stay, thus increasing economic growth in the long run. The kit will not only be used to diagnose OA at early stages, but it has the potential to investigate OA progression of patients undergoing conservative treatments on the long-term. Moreover, it is a valuable tool to plan patient-specific approaches for personalised therapy.
This OA IVD kit will represent a major business opportunity for the BIOFOSTE team, as it will provide access to the IVD market and will result in high revenues, with an expected cumulative profit of € 69 Million by 2025.

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