Anatomy of a diagnostic test

Presented By: Sidney Yee, PhD

Speaker Biography: Sidney is CEO of DxD Hub and Senior Advisor at A*ccelerate. DxD Hub focuses on accelerating productisation of innovative diagnostic technologies. To address testing and management needs of COVID-19, DxD Hub developed and deployed conventional RT-PCR test Fortitude, serological test cPass, saliva collection and transport media, Lucence's SAFER and direct PCR test RESOLUTE. DxD Hub has the capability to rapidly translate R&D output from public and private sectors, into deployable products in hospitals. Fortitude was the first diagnostic kit to be granted provisional authorisation by Singapore’s HSA and is now deployed in more than 40 countries globally. RESOLUTE is first-of-its-kind completely extraction-free RT-PCR based test that completes sample-to-result in an hour. A serial entrepreneur with experience in R&D, starting companies and investments prior to joining A*STAR, Sidney continues to be involved in med-tech and innovation. She cofounded multiple companies, serves as non-executive board member of several companies, and as a reviewer on various diagnostics/medtech funding schemes.

Webinar: Anatomy of a diagnostic test

Webinar Abstract: 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.