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Feasibility study for clinical validation of an innovative point of care assay for the detection of low-grade-infections in joint replacement

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

Joint replacement by endoprosthesis is a common and successful surgical intervention. In Europe there are more than one million hip and knee replacements in a year and over 3 million worldwide. With the lack of adequate diagnostic methods, up to 15% of implant revision surgeries fail due to the undetected presence of infections. This high number of inadequate surgeries results in pain and further health risks for patients and extends the expenses for hospitals and the health care systems. QuantOnCal, a reliable, quantitative point of care immune assay, can detect low-grade-infections in joint synovial fluid.
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.
During the reporting period the following results were achieved by performing the work according to the objectives of the feasibility study:
• 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 final results of the feasibility study (phase 1) are the feasibility report and the proposal for the call H2020-SMEINST-2-2015 submitted 25 November 2015.
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%.
The novel QuantOnCal assay for analysis in less than 15 minutes without any laboratory