Periodic Reporting for period 1 - QuantOnCal (Feasibility study for clinical validation of an innovative point of care assay for the detection of low-grade-infections in joint replacement)
Reporting period: 2015-06-01 to 2015-10-31
Objectives of the feasibility study (phase 1) were: Establishing the low grade infection assay QuantOnCal, patent application, gaining detailed market survey, setup of a multicentre clinical study, preparation of a business plan.
• Low grade infection assay QuantOnCal has been established which combines two parameters.
• Patent application for the QuantOnCal assay has been filed.
• Detailed information on potential clinical market and regulatory requirements has been gained.
• A European wide consortium for a multicentre clinical study has been established.
• An elaborated business plan has been prepared.
The potential impact and use of these results will be the opportunity to conduct a large clinical validation study, which will demonstrate the simplicity, accuracy, reliability and predictive power of QuantOnCal. This will finally pave the way for full exploitation and licensing of the test as a medical device.
The socio economic impact and the wider societal implications will be: QuantOnCal assay will be applied in operation theatre and thus physicians can decide on the right therapy. By this they can improve the management of infections in joint replacement and avoid non-promising surgeries and revisions. Therefore health and quality of life for patients could be improved tremendously and surgery costs could be reduced by 35%.