Anatomy of a diagnostic test

This presentation introduces the process of accelerated productization, pioneered by Diagnostics Development (DxD) Hub. DxD Hub is a Singapore national platform for diagnostics development and productization, funded by the National Research Foundation and hosted by the Agency for Science, Technology and Research (A*STAR). The key to accelerated productization lies in (i) end-to-end productization: understanding user requirements, and developing the regulatory framework of minimal viable product based on format of the end product; and (ii) agile iterative process: quick succession of iteration based on evolving market and user input. DxD Hub model is based on that of a public-private partnership involving R&D entities, clinical community and commercial parties. Using the example of RESOLUTE - a direct polymerase chain reaction (PCR) test, this presentation illustrates the productisation journey of a diagnostic test. RESOLUTE received provisional authorisation from the Health Sciences Authority in April 2020, and is a collaboration between Defence Science Organisation, Advanced Remanufacturing Technology Centre, and commercial partner Advanced Medtech.