The Institute of Cancer Research
Companion diagnostic assays for personalised therapies in gastrointestinal cancers that use robust gene-expression biomarkers.
Colorectal cancer is the second leading cause of death for cancer worldwide, with more than 800,000 deaths annually. Precision medicine and immunotherapy have been extremely successful in treating multiple types of cancer; unfortunately, only minor effects have been seen in the vast majority of colorectal cancer patients. Part of this failure is due to the lack of robust biomarkers that can easily be tested to facilitate treatment decisions.
We have identified molecular biomarkers (Sadanandam et al, Nature Medicine 2013) which have been patented, to develop an easy-to-use test to predict the type of response to the only available targeted agents in the UK for this highly lethal disease (anti epidermal growth factor receptor drugs) (Ragulan et al, bioRxiv 2017, Fontana et al, ascopubs.org 2018). The technology used for the test is widely available in pathology laboratories and has a clinically-relevant turn-around time for routine clinical application; it is performed on already available diagnostic tissue (no need for further invasive tests or biopsies in patients). These characteristics are particularly suitable for prospective validation.
Once validated in a clinically accredited laboratory, we envisage the test will directly impact on patients’ care. The use of a robust selection method, such as this test, will screen for patients who will not benefit from these drugs avoiding unnecessary toxicities and time spent in hospital instead of with family and friends in last months of their life. This will also ultimately result in the redistribution of health care funding to ensure that all patients with a high likelihood of a positive response will have access to these drugs beyond current restrictions, with an overall cost reduction for healthcare systems and improved patient outcomes.
Diagnostics Accelerator Programme: market access planning and evidence generation
Delivered in partnership with the National Institute of Health Research London In Vitro Diagnostics unit this six-week evidence generation focused programme will support medtech innovators to de-risk the path to successful deployment through the development of a business case validating their clinical, financial and social claims. This way, when innovators approach the health system, they are comfortable in the knowledge that the product achieves what it is designed to do.Applications Open (closing 7 March 2021)