A rapid and cost-effective point-of-care diagnostic kit able to predict treatment response for appropriate Multiple Sclerosis management

Project Information

ScleroTest

Grant agreement ID: 867463

DOI

10.3030/867463

Project closed

EC signature date 20 May 2019

Start date 1 June 2019

End date 30 November 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

BIOITHAS SL
Spain

Periodic Reporting for period 1 - ScleroTest (A rapid and cost-effective point-of-care diagnostic kit able to predict treatment response for appropriate Multiple Sclerosis management)

Reporting period: 2019-06-01 to 2019-11-30

Summary of the context and overall objectives of the project

Multiple Sclerosis (MS) is a chronic and impairing neurological disease that affects 2.5 million people worldwide and has no cure. The impact of MS implies €15.5B annual of socioeconomic costs only in Europe. It is urgent to stop brain deterioration on time by accessing effective and early treatment. Although current treatment, disease-modifying therapy (DMTs), have improved patient’s quality of life, 20-50% of patients do not respond adequately to the prescribed treatment. In Bioithas, we have developed ScleroTest, the first-ever rapid, cost-effective, gut biomarker-based diagnostic kit to predict treatment response of each MS patient. The final objective of the project is to achieve the full development of ScleroTest and to successfully commercialize it as a rapid and non-invasive diagnostic test for MS.

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

ScleroTest has proven to be reliable in a 3-year pre-clinical study, in which we identified specific bacteria species that are only found on the gut of MS patients with a poor response to treatment. From this, ScleroTest is designed as a q-PCR diagnostic kit to be tested on MS stool patients. However, still, we must optimize the design by determining the specific PCR reaction parameters and test its efficacy in a relevant clinical environment. Thus, after optimization, we will manufacture ~900kits to test in a clinical study. Later, we will obtain the CE mark and FDA clearance for market approval and ScleroTest will enter the in vitro diagnostic market (expected to reach USD 87.9B in 2023). In 5 years, it will generate €45M in revenues, serving 376k MS patients throughout Europe and the US. We estimate a need for €1,7M to reach the market and an additional €1,2M in further post-market commercialization activities.

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)

Current tools in the clinical practice are used to predict the prognosis of disease through invasive and not reliable procedures. ScleroTest will provide healthcare professionals with a disruptive, accurate (PCR technology), non-invasive (stool sample), rapid (<24h), easy-to-use, cost-affordable and reliable diagnostic tool to anticipate the response of MS patients to treatment. It will help physicians in their decision-making of the most effective therapy and bring precision medicine into the MS landscape. Healthcare systems will benefit from a cost-affordable tool and avoid expenses of ineffective treatment, thus implying €2.1B annually for the European healthcare systems. Consequently, patients will benefit from early access to personalized treatment implying better management of their condition and better treatment outcomes.

Schematic procedure of ScleroTest diagnosis