10172305Novel Isothermal Nucleic Acid Amplification technology and Its Potential Use for Decentralised Cancer DiagnosticsClosedFast Start ResponseInnovate UKAccess to timely, accurate diagnostic testing remains a significant global health challenge, especially for people in remote, underserved, or low-resource settings. Today's molecular diagnostics often depend on expensive instruments, laboratory infrastructure, electricity, and highly trained personnel, making them inaccessible to many who need them most. These barriers delay diagnoses, widen health inequalities, and reduce chances of effective treatment, particularly for aggressive diseases like lung cancer. Lung cancer is the world's deadliest cancer and the UK's third most common, with over 50,000 new cases annually. It accounts for more than 35,000 UK deaths each year, and globally, causes nearly 1.8 million deaths. Early detection is vital, but access to precision testing for key genetic mutations (such as EGFR) is often limited due to cost and centralised lab reliance. This represents a critical bottleneck in improving survival rates and equitable cancer care. At Simplex Molecular, our mission is to democratise access to high-quality molecular testing through decentralisation. We are developing RINAA(tm) (Room-Temperature Isothermal Nucleic Acid Amplification), a novel, instrument-free method that works entirely at ambient temperatures (16--26°C). Unlike traditional PCR or LAMP technologies, RINAA(tm) removes the need for heating, read-out instruments and complex lab processes, making it suitable for point-of-care, community clinics, or even at-home testing. In this project, we will validate the use of RINAA(tm) for non-invasive lung cancer diagnostics, beginning with the development of a prototype assay to detect EGFR mutations that could be used using cell-free DNA (cf-DNA) from blood plasma. This innovation has the potential to support earlier diagnosis and more personalised treatment decisions in oncology. The global lung cancer diagnostics market is projected to reach over $7.35 billion by 2034, highlighting the urgent need for scalable, accessible solutions. Beyond cancer, RINAA(tm) has broad potential across a wide range of diagnostic applications, including sexually transmitted infections (STIs), antimicrobial resistance (AMR), and epidemic preparedness. Its versatility also extends to animal health, food safety, and environmental monitoring, offering impactful solutions across both human and non-human sectors. With RINAA(tm), we aim to redefine the future of diagnostics and contribute to the UK's leadership in life science innovation. Our vision is to disrupt and transform where and how molecular testing is performed, making high-quality diagnostics accessible far beyond traditional laboratory settings. We believe RINAA(tm) is a highly scalable, versatile platform with a strong technological foundation and the potential to become a cornerstone in the next generation of decentralised diagnostics.