Periodic Reporting for period 1 - MultiDiag (Rapid, cost-effective, multiplex point of care diagnostic immunoassay system)
Période du rapport: 2015-07-01 au 2015-12-31
Allergic conditions, autoimmune diseases and infectious diseases represent significant areas of interest for the diagnostics industry. Autoimmune responses result from a dysfunction of the immune system; the body produces an immune response against its own tissues, attacking its own organs, tissues, and cells. There are >80 types of autoimmune disorders, including thyroid and coeliac disease. Diagnosis requires the detection of relevant antibodies (which act as biomarkers). There is a growing requirement for new diagnostic tools to lessen the time to diagnosis (AARDA). NALIA have identified an opportunity to develop a rapid, cost-effective immunoassay, which detects multiple biomarkers within 20 mins at the point of care.
At the time of applying for Phase 1, the key benefits proposed for the innovative solution included:
• Multiplexed tests at the point of care – panels of high-numbers of biomarkers can be tested whilst retaining the sensitivity, accuracy & quantification benefits of standard ELISA tests;
• Provide results for multiple markers of disease simultaneously;
• Provide quantitative results within 20 mins (using microfluidics & automated processing);
• Reduce the timescale to diagnosis, shortening the number of specialist visits by patients seeking a diagnosis;
• Benchtop device easily accommodated in point of care setting;
• Reduced cost of using expensive laboratory services and consultant clinician time.
At the conclusion of the feasibility study we have been able to confirm:
• Overall assay time reduced to 21 minutes so far - 72 minutes saved; there is potential for further time reduction.
• Three marketing studies have shown that there is an existing and growing market place for immune-diagnostics in the three areas selected for future exploitation – allergies, auto-immune diseases and infectious diseases. In terms of these potential market segments, the significant message is that all are large and growing. NALIA could therefore potentially explore and exploit these three opportunities. Most importantly though is that there is currently little or no provision of point-of-care testing, except to some extent in allergy, so introduction of effective tests at the point-of-care, which NALIA proposes would be a disruptive change to the market.
• Additionally, significant progress has been made with partners in terms of plate readers, cartridges and printing, and these will form a potential consortium for Phase 2. Initial discussions have taken place with potential clinical partners with proven expertise in relevant areas. These discussions with clinicians have shown that NALIA point-of-care tests would be readily adopted in this sector where testing is largely done by specialist centres often requiring a process in which the clinician interacts with the patient for 30min or more and/or over 2-3 days. Furthermore, current testing methods are not patient-friendly. A faster, more comprehensive and very patient-friendly system would be very attractive in this sector.
• A Risk Assessment was undertaken, relating to the uptake and implementation of the technology, which will be further enhanced in the Phase 2 Project.
• Multiplexed tests at the point of care – panels of high-numbers of biomarkers can be tested whilst retaining the sensitivity, accuracy & quantification benefits of standard ELISA tests;
• Provide results for multiple markers of disease simultaneously;
• Provide quantitative results within 20 mins (using microfluidics & automated processing);
• Reduce the timescale to diagnosis, shortening the number of specialist visits by patients seeking a diagnosis;
• Benchtop device easily accommodated in point of care setting;
• Reduced cost of using expensive laboratory services and consultant clinician time.
At the conclusion of the feasibility study we have been able to confirm:
• Overall assay time reduced to 21 minutes so far - 72 minutes saved; there is potential for further time reduction.
• Three marketing studies have shown that there is an existing and growing market place for immune-diagnostics in the three areas selected for future exploitation – allergies, auto-immune diseases and infectious diseases. In terms of these potential market segments, the significant message is that all are large and growing. NALIA could therefore potentially explore and exploit these three opportunities. Most importantly though is that there is currently little or no provision of point-of-care testing, except to some extent in allergy, so introduction of effective tests at the point-of-care, which NALIA proposes would be a disruptive change to the market.
• Additionally, significant progress has been made with partners in terms of plate readers, cartridges and printing, and these will form a potential consortium for Phase 2. Initial discussions have taken place with potential clinical partners with proven expertise in relevant areas. These discussions with clinicians have shown that NALIA point-of-care tests would be readily adopted in this sector where testing is largely done by specialist centres often requiring a process in which the clinician interacts with the patient for 30min or more and/or over 2-3 days. Furthermore, current testing methods are not patient-friendly. A faster, more comprehensive and very patient-friendly system would be very attractive in this sector.
• A Risk Assessment was undertaken, relating to the uptake and implementation of the technology, which will be further enhanced in the Phase 2 Project.
The project will now continue with an application to the SME instrument Phase 2 due to be submitted by the April 14th 2016 cut-off deadline, where the innovation and demonstration activities will include
• Development and testing of engineering prototypes of the disposable cartridge and the point-of-care reader device
• Develop reagent system suitable for storage at room temperature
• Define antigen panels for each disease area in conjunction with clinical experts
• Field trials with key opinion leaders
• Value engineering and development of full pre-production prototypes
• Filing for CE Marks
• Development and testing of engineering prototypes of the disposable cartridge and the point-of-care reader device
• Develop reagent system suitable for storage at room temperature
• Define antigen panels for each disease area in conjunction with clinical experts
• Field trials with key opinion leaders
• Value engineering and development of full pre-production prototypes
• Filing for CE Marks