Periodic Reporting for period 2 - ALA DIAGNOSTICS MS KIT (Revolutionising the diagnosis of multiple Sclerosis with the first bioinformatic diagnostic kit that allows early detection with a simple blood test)
Periodo di rendicontazione: 2024-02-01 al 2025-07-31
MS affects around 700,000 people in Europe and 2.8 million people worldwide. It is the most common chronic neurological disease in young adults in developed countries, and the main cause of disability after traffic accidents.
Current diagnosis process takes one year (on average), which combined with the high rate of misdiagnoses (20%) makes pharmacological treatment start late which produces irreversible damage in patients and a worse prognosis. The high cost associated with MS treatment makes that misdiagnosis also leads to a healthcare over cost of around €20 B/yr.
In this context, ALA DIAGNOSTICS MS KIT is a kit for in vitro diagnosis of MS in blood (serum) suitable for early diagnosis of MS. It is based on a patented recombinant protein whose activity as a diagnostic biomarker has already been clinically validated in 598 human samples.
Our kit represents a new strategy for the diagnosis of MS based on the determination of sIFNAR2 levels in a biological fluid (serum) and it is carried out by an enzyme-linked immunosorbent assay (ELISA).
The availability of a diagnostic kit like ours will help a large number of people who suffer from a highly relevant disease.
Our overall objectives were:
1. Prototype development: Generation and validation of an industrial prototype are aimed at the design and generation of a diagnostic test in kit format, by optimising the components of this test, with the objective of improving the sensitivity and specificity of the technique, as well as the robustness and consistency of our diagnostic kit.
2. Complete the development of our Diagnostic algorithm and informatic tool: To further develop a diagnostic algorithm to complement the Diagnostic Kit that integrates, in addition to the results of this kit, the main paraclinical variables associated with the diagnosis of Multiple Sclerosis, to obtain the best possible and cost-efficient combination for clinical use.
3. Perform an international clinical trial to obtain CE Mark and FDA Approval.
4. Validate our Biomarker for subclinical MS diagnosis.
5. Launch negotiations with market players to reach distribution and licensing agreements with distributors and multinational IVD companies.
Current diagnosis process takes one year (on average), which combined with the high rate of misdiagnoses (20%) makes pharmacological treatment start late which produces irreversible damage in patients and a worse prognosis. The high cost associated with MS treatment makes that misdiagnosis also leads to a healthcare over cost of around €20 B/yr.
In this context, ALA DIAGNOSTICS MS KIT is a kit for in vitro diagnosis of MS in blood (serum) suitable for early diagnosis of MS. It is based on a patented recombinant protein whose activity as a diagnostic biomarker has already been clinically validated in 598 human samples.
Our kit represents a new strategy for the diagnosis of MS based on the determination of sIFNAR2 levels in a biological fluid (serum) and it is carried out by an enzyme-linked immunosorbent assay (ELISA).
The availability of a diagnostic kit like ours will help a large number of people who suffer from a highly relevant disease.
Our overall objectives were:
1. Prototype development: Generation and validation of an industrial prototype are aimed at the design and generation of a diagnostic test in kit format, by optimising the components of this test, with the objective of improving the sensitivity and specificity of the technique, as well as the robustness and consistency of our diagnostic kit.
2. Complete the development of our Diagnostic algorithm and informatic tool: To further develop a diagnostic algorithm to complement the Diagnostic Kit that integrates, in addition to the results of this kit, the main paraclinical variables associated with the diagnosis of Multiple Sclerosis, to obtain the best possible and cost-efficient combination for clinical use.
3. Perform an international clinical trial to obtain CE Mark and FDA Approval.
4. Validate our Biomarker for subclinical MS diagnosis.
5. Launch negotiations with market players to reach distribution and licensing agreements with distributors and multinational IVD companies.
The work carried out during the project has been in line with what was foreseen in the Grant Agreement, having completed the development of the diagnostic kit after overcoming some technical barriers that forced us to produce two new versions of the diagnostic kit. These additional developments provoked a general delay in the project execution that forced us to request a project extension to conduct the clinical trial required for the regulatory clearance of the kit. Unfortunatelly, the amendment requested to extend the project was not approved and as a consequence the clinical trial was not performed within the frame of the project. We plan to implement it thorugh other means after the official project finalization has been confirmed.
So far, the company has completed the development of the first industrial prototype of the MS diagnostic Kit.