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A Novel Detection protocols for REliable prostate cancer Assays

Project description

A novel diagnostic kit for reliable early prostate cancer detection

The use of the prostate-specific antigen (PSA) as a diagnostic marker in the early detection of prostate cancer often complicates diagnosis with false-positive or false-negative results. This approach measures changes in the glycan (complex carbohydrate) composition of the PSA. Funded by the European Research Council, the Andrea project aims to design, validate and commercialise a robust clinical kit for the accurate early diagnosis of prostate cancer. It will develop and evaluate a magnetic bead-based assay for lectins using 140 biobank samples. A retrospective validation study of the assay by statistical analysis will follow, using a receiver operating characteristic curve for the panel of 450 human serum samples.

Objective

The technology validation was successfully completed indicating a great commercial potential, and the innovative and inventive aspects of the assay platform are now covered by the filed priority European Patent Office (EPO) patent applications. Validated glycoprofiling of the proteins now uses lectins in a format, fully compatible with clinical PSA assay kits. This PoC grant focuses on 1. Pre-clinical retrospective validation of the early stage biomarker of prostate cancer (PCa) and 2. Commercialisation of the PCa diagnostics kit. Pre-clinical (60 human serum samples) is ongoing and retrospective validation study (450 human serum samples) of the assay will be performed by statistical analysis using a receiver operating characteristic (ROC) curve. The PoC describes all steps, which have been developed so far and all necessary steps, which need to be done for retrospective validation study, product development and commercialisation through our newly incorporated start-up Glycanostics Ltd. (www.glycanostics.com). We will provide PCa diagnostic test resulting in a second opinion to guide the right decision if the biopsy is needed. This will avoid the needless and unreliable biopsies and in the future rival an inaccurate PSA testing.

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Coordinator

CHEMICKY USTAV SLOVENSKEJ AKADEMIEVIED
Net EU contribution
€ 87 500,00
Address
Dubravska cesta 9
845 Bratislava
Slovakia

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Region
Slovensko Bratislavský kraj Bratislavský kraj
Activity type
Research Organisations
Links
Other funding
€ 0,00

Beneficiaries (2)