Periodic Reporting for period 1 - PAPRAT (PAPRAT (Predictive Algorithm for Pre-Rheumatoid Arthritis Treatment). The new and most efficient multiple biomarkers-based system for an early selection of RA treatment intensity)
Berichtszeitraum: 2019-09-01 bis 2020-02-29
Making Genetics is focus on develop new diagnostic and prognosis tools through genomic approaches for clinical use. Granted by a SME-Phase 1 prepared the pre-commercial phase of PAPRAT (Predictive Algorithm for Pre-Rheumatoid Arthritis Treatment), a clinical service for treatment personalization at the earliest stages of rheumatoid arthritis (RA) (pre-RA, undifferentiated arthritis, very early RA or recent onset RA).
RA is a relevant source of disability worldwide with high impact in patient’s quality of life and a relevant economic burden with increasing associated cost. Early start of effective therapy is crucial for RA management; however, there are not accurate prognosis factors for pre-RA.
PAPRAT, is a biomarker-based prognosis system capable of classifying pre-RA patients (a clinical stage in which early intervention is more advantageous to patients and health care systems) and discerning which will need an early intensive treatment to control or their disease.
The goal of the PAPRAT project is to give an easy, precise, effective and efficient tool to assist rheumatologist on therapeutic management, improving current clinical practice at pre-RA. The Phase 1 intended to set up clinical validation, cloud-based platform, regulatory requirements (e.g. demonstration of clinical performance, security and quality for commercial approval), identify and contact stakeholders and perform a market and financial analysis.
RA is a relevant source of disability worldwide with high impact in patient’s quality of life and a relevant economic burden with increasing associated cost. Early start of effective therapy is crucial for RA management; however, there are not accurate prognosis factors for pre-RA.
PAPRAT, is a biomarker-based prognosis system capable of classifying pre-RA patients (a clinical stage in which early intervention is more advantageous to patients and health care systems) and discerning which will need an early intensive treatment to control or their disease.
The goal of the PAPRAT project is to give an easy, precise, effective and efficient tool to assist rheumatologist on therapeutic management, improving current clinical practice at pre-RA. The Phase 1 intended to set up clinical validation, cloud-based platform, regulatory requirements (e.g. demonstration of clinical performance, security and quality for commercial approval), identify and contact stakeholders and perform a market and financial analysis.
We reached all objectives planned. We performed a technical, commercial and financial risk analysis and stablished preliminary mitigation measures. We analyzed and documented the activities and requirements to evaluate the efficacy, security and quality for PAPRAT conformity assessment, including software platform development, clinical trials, post-market surveillance plan, identification, and contact with stakeholders for PAPRAT lifecycle. We defined the marketing and scale up plan, and the financial needs of the project to finally build-up a complete and integrated work plan for the next years.
PAPRAT will enable higher precision, effectives and efficiency in patient’s prognosis to assist clinicians in prescribing a personalized treatment and early implementation of the most suitable treatment for management pre-RA. Positive outcomes will improve the health and the quality of life of patients and reducing disability and the associated cost to RA
We are going to apply for next phase 2 call to implement phase 1 work plan and reach market.
We are going to apply for next phase 2 call to implement phase 1 work plan and reach market.