Title: GlycoScore: Superior prostate cancer diagnosis using a simple blood test
Funder: Department of Health and Social Care

Abstract: Background: Prostate cancer is the most common cancer in the UK, affecting one in every eight men within their lifetime. Current diagnosis relies on PSA tests which detect Prostate Specific Antigen in patient blood. PSA has a high false-positive rate and over-diagnoses >60% of healthy patients. This means that many healthy men undergo unnecessary prostate biopsies , which are invasive, can be painful and carry the risk of infection, incontinence and erectile dysfunction. GlycoScore is a patented blood test that has the potential to revolutionise how prostate cancer is diagnosed. GlycoScore provides unmatched performance when compared to existing non-invasive tests for prostate cancer. The test has high sensitivity (93%) and importantly also has a high specificity (98%) (PSA sensitivity: 85%, specificity: 33%). This means GlycoScore has superior diagnostic power to identify men with prostate cancer but will also drastically reduce over-diagnosis. GlycoScore detects 3 protein biomarkers in patient blood using an analytical method called 'ELISA' (the same method used to detect PSA). This makes our test easily adoptable by pathology labs worldwide without additional capital investment. GlycoScoreDx Ltd are currently working with sub-contractors to develop a prototype ELISA test for GlycoScore and obtain CE marking. The use of GlycoScore will mean that only men with a high risk of prostate cancer need to undergo tissue biopsies. Based on this, we estimate that adoption of GlycoScore could save the NHS up to &pound;45 million/year. Aims: This project aims to: 1) generate robust clinical evidence further validating GlycoScore as a superior diagnostic test for prostate cancer, and 2) define where in the patient care pathway GlycoScore has the most value. Design of the project: GlycoScoreDx will work with the Newcastle In Vitro Diagnostics Cooperative to perform optimisation and validation of GlycoScore. We will also carry out care pathway analysis and heath economic modelling. This will be essential to guide product development and future clinical trial design. Together these activities are expected to generate data to support an NIHR i4i Product Development Award to enable GlycoScore to be tested in a prospective clinical trial (and generate the clinical evidence needed for widespread adoption of GlycoScore). Patient and public involvement: Our team has strong links with Prostate Cancer UK and patient groups. Two patient groups will be closely involved in the project and will help define the clinical need and potential role(s) for GlycoScore, and ensure the final use and purpose of GlycoScore meets the patient need and benefits the patient population. Dissemination: We shall ensure that we feedback to the patients on the outcomes and final findings of the research and will seek their advice and guidance how we further disseminate and engage patients in the final research findings for their knowledge and benefit.

Lay abstract: Background: Prostate cancer is the most common cancer in the UK, affecting one in every eight men within their lifetime. Current diagnosis relies on PSA tests which detect Prostate Specific Antigen in patient blood. PSA has a high false-positive rate and over-diagnoses >60% of healthy patients. This means that many healthy men undergo unnecessary prostate biopsies , which are invasive, can be painful and carry the risk of infection, incontinence and erectile dysfunction. GlycoScore is a patented blood test that has the potential to revolutionise how prostate cancer is diagnosed. GlycoScore provides unmatched performance when compared to existing non-invasive tests for prostate cancer. The test has high sensitivity (93%) and importantly also has a high specificity (98%) (PSA sensitivity: 85%, specificity: 33%). This means GlycoScore has superior diagnostic power to identify men with prostate cancer but will also drastically reduce over-diagnosis. GlycoScore detects 3 protein biomarkers in patient blood using an analytical method called 'ELISA' (the same method used to detect PSA). This makes our test easily adoptable by pathology labs worldwide without additional capital investment. GlycoScoreDx Ltd are currently working with sub-contractors to develop a prototype ELISA test for GlycoScore and obtain CE marking. The use of GlycoScore will mean that only men with a high risk of prostate cancer need to undergo tissue biopsies. Based on this, we estimate that adoption of GlycoScore could save the NHS up to &pound;45 million/year. Aims: This project aims to: 1) generate robust clinical evidence further validating GlycoScore as a superior diagnostic test for prostate cancer, and 2) define where in the patient care pathway GlycoScore has the most value. Design of the project: GlycoScoreDx will work with the Newcastle In Vitro Diagnostics Cooperative to perform optimisation and validation of GlycoScore. We will also carry out care pathway analysis and heath economic modelling. This will be essential to guide product development and future clinical trial design. Together these activities are expected to generate data to support an NIHR i4i Product Development Award to enable GlycoScore to be tested in a prospective clinical trial (and generate the clinical evidence needed for widespread adoption of GlycoScore). Patient and public involvement: Our team has strong links with Prostate Cancer UK and patient groups. Two patient groups will be closely involved in the project and will help define the clinical need and potential role(s) for GlycoScore, and ensure the final use and purpose of GlycoScore meets the patient need and benefits the patient population. Dissemination: We shall ensure that we feedback to the patients on the outcomes and final findings of the research and will seek their advice and guidance how we further disseminate and engage patients in the final research findings for their knowledge and benefit.

Research activity codes: 4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: CANCER AND NEOPLASMS