UK market access strategy for AlphaBiomics’ novel precision medicine diagnostic test RxSelex™

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**HEALTHCARE CHALLENGE:** Immune-mediated diseases are lifelong illnesses characterized by an abnormal reaction of the body's immune system, known as inflammation. Examples are Crohn's disease (CD) and ulcerative colitis (UC). People who experience severe disease whose activity cannot be controlled with the usual medication are typically treated with a biologic drug to stop inflammation. This type of medicine is made of materials also found in living organisms. Typically, individuals with the same disease are initially treated with the same type of biologic drug. However, individual patients respond very differently to the same biologic drug. Some may benefit, whereas others do not, or have unwanted side effects. The continued need for hospital visits and uncertainty of treatment success has been especially difficult for these immuno-compromised patients during the COVID-19 pandemic.**ALPHABIOMICS' SOLUTION:** The gut microbiome (the large and complex community of typically harmless bacteria in our intestines) has an important influence over biologic drug response. AlphaBiomics is developing a non-invasive at-home test for CD and UC patients that predicts a person's likely response to biologic drugs as a group. This test, called RxSelex(tm), measures important gut microbiome components found in a patient's stool. Once this diagnostic test is ready for use, it will be sold to the NHS.**FAST PROJECT AIM:** The NHS is currently undergoing major changes in how health and care services are planned, obtained, paid for, and delivered. New Integrated Care Systems (ICSs) have been established to aggregate providers and commissioners of NHS services across a geographical area with local authorities and other local partners to collectively plan health and care services to meet the needs of regional population. NHS reorganisation into ICSs is changing adoption and ordering pathways including for diagnostic tests like RxSelex(tm). The aim of this project is to develop a clear roadmap for NHS adoption and dissemination of RxSelex(tm) that fits the novel ICS structure.**FAST WORK PLAN:** AlphaBiomics will engage the expert consultancy Hardian Health to deliver this roadmap. Hardian will review publicly available information regarding adoption and purchasing of diagnostic tests. They will also estimate the number of IBD patients in the UK who will benefit from RxSelex(tm). Hardian will then interview experts to confirm or update their findings and then summarise the results in a roadmap.