50425Developing MetaGuideX, a rapid test for determining metastatic status in breast cancer.ClosedStudyInnovate UKThe management of breast cancer, which affects \>2 million new patients globally each year, is inadequate. In particular, we need better ways to: -detect whether metastasis (deadly spread of cancer to other parts of the body) has occurred -predict whether metastasis will occur in future -assess whether therapy is working well -detect the return of the tumour more quickly If we could do these better, doctors could decide on the best therapy for a given patient more quickly. The therapy is more likely to work and the patient is more likely to survive. Healthcare providers, such as the NHS, would save money by avoiding ineffective treatment, and a healthier population improves the national and global economy. Through our research into breast cancer metastasis we have discovered a protein present only in tumours with metastatic ability. This innovative biological marker could be used to tell doctors about the metastatic status of a tumour. Our innovative step is to turn this discovery into a diagnostic test, which we call MetaGuideX. Our test can be performed on the tumour itself, or on fragments of the cancer cells released into the bloodstream. The test meets an unmet clinical need, and can be used at the point of diagnosis, during treatment (to see if the therapy is effective) and during remission (to see if the tumour has returned). Our vision is to fundamentally change the way that breast cancer is managed, by introducing our test to hospitals and clinics, and setting up a 'service lab' to run the test for those who don't have the facilities to run it themselves. There are three important objectives we will achieve in order to lay down the foundations for our long-term ambition. We will: 1.Develop a prototype diagnostic and test it on a panel of breast cancers to establish its performance and potential to impact breast cancer management 2.Establish the proper regulatory systems and protocols needed for a diagnostics company. These complex regulations are enforced by UK and global agencies and we must implement them from the outset to prevent delay in getting the test into the clinic 3.Engage with stakeholders to facilitate the uptake of an optimal test in the clinic. Achieving these objectives will allow us to gain further funding and expand the company, initially benefiting the NHS and then healthcare providers across the world, delivering social and economic impact as we grow.