Title: CanSense-CRC : Development and optimisation of a blood test for the early detection of bowel cancer in primary care
Funder: Department of Health and Social Care

Abstract: Research Question Can the CanSense-CRC blood test be developed to the required conformity and standard as a primary care decision support tool to detect colorectal cancer earlier? Background Late stage detection creates poor colorectal cancer outcomes. Diagnostic pathways are high cost and low yield, with poor patient experience. There is need to improve detection tools, optimise pathways and improve survival. CanSense is developing an accurate, rapid cancer detection blood test for use as a diagnostic tool. The test produces a spectral fingerprint from cancer activity in blood that AI-pattern recognition software interprets to detect colorectal cancer and pre-malignant polyps. Aims/ objectives Develop and evaluate the innovation for efficacy and safety in detection of colorectal cancer and polyps in the intended population. Produce regulatory and health economic data towards CE/UKCA marking. Methods Workplans WP1 tests the prototype instrument with existing blood spectra and shared clinical data from 1,200 previously recruited primary care patients to deliver optimised performance and conformance data for the intended population. WP2 will complete development of the AI algorithm using High Performance Computing with a performance evaluation study in readiness for clinical evaluation. WP3 will accredit the CanSense laboratory to appropriate ISO standards and commence instrument migration into an NHS laboratory. WP4 works towards CE/UKCA marking for the AI algorithm with specialist software regulatory advice and quality management processes. WP5 conducts health economic analyses of our technology compared to standard practices. WP6 supports patient/ public engagement and professional panel focus groups to determine wider clinical acceptability through behavioural science. WP7 supports strong project management arrangements to ensure the project is delivered on time and within budget with PPI partners. We have identified a clear route to market with Swansea Bay University Health Board as early adopter with spread/scale in England and Wales. Timelines for delivery Instrument development (months 0-12) and AI algorithm testing (months 0-24) concurrent with other work packages. Anticipated Impact and dissemination At Project Exit CanSense-CRC diagnostic test market-ready with clinical efficacy data, safety data, regulatory data, patient metrics, CE/UKCA readiness, health economic data, ready to achieve CE/UKCA marking for the AI. Dissemination through NHS, academic and PPI partners will help achieve our goal of NHS adoption for NHS patient benefit. Long term impact of the work is earlier stage of detection of colorectal cancer with improvements in survival rates for this common and preventable cancer. CanSense recognises the need for larger commercial partnerships with already established NHS suppliers to facilitate NHS adoption and scale through existing procurement pathways. We are focussed on developing commercial relationships with our established academic collaborators e.g. Siemens, PerkinElmer, Roche and Renishaw.

Lay abstract: Aims The aim of our research project is to develop a blood test to detect the earliest stages of colorectal (bowel) cancer. Detecting cancer early allows it to be treated more simply and effectively and makes it more likely to be cured. The blood test could help GPs refer patients with bowel symptoms more effectively. The test would allow a faster diagnosis of cancer to speed up treatment starting. Those patients whose test is normal can be reassured by their GP without the need for hospital referral. Background Bowel cancer is a leading cause of cancer related deaths worldwide. Early detection can cure the cancer but as symptoms of bowel cancer are vague it is difficult to diagnose early. Many symptomatic patients are referred for a costly and unpleasant colonoscopy. Most colonoscopies prove to be normal and could be avoided. The large number of referrals delays those who do in fact have underlying cancer being seen. There is a real need for faster and less invasive detection methods. Our test uses lasers to detect cancer activity in the blood test. A computer program analyses the laser signal to say if cancer is likely or not. Early results indicate that the blood test is highly accurate at detecting bowel cancer and the polyps that can turn cancerous. The blood test may also be used to detect cancer in other parts of the body earlier. Design/ Methods This project will develop the testing device and the software program to be ready for NHS use. We will test the accuracy and safety of the blood testing system and see if the test can be cost saving. The project has 7 workstreams: To make the testing instrument smaller suitable for use in an NHS laboratory. To develop the software programme to make it as accurate as possible. To ensure that our testing lab meets the correct standards To prepare the software for regulatory approval ready for use Conduct an economic cost/benefit analysis of the product compared to current tests Work with patients, public and professionals to understand the acceptability of our test Managing the project so it is delivered on time and within budget Patient/Public Involvement We have involved patients from the start of our project - confirming that the need for an acceptable and accessible cancer blood test is at the heart of our development. We will work with patients and the public to design, deliver and disseminate our project. Dissemination We will share our results through government, academic, NHS and PPI partners, across social media, publications and news releases to help achieve NHS adoption for patient benefit.

Research activity codes: 7.3 MANAGEMENT AND DECISION MAKING;4.1 DISCOVERY AND PRECLINICAL TESTING OF MARKERS AND TECHNOLOGIES
Health categories: CANCER AND NEOPLASMS