Even though medical diagnosis can be traced back to ancient Egypt in the 26th century BC (Edwin Smith Papyrus by Imhotep), in vitro diagnostics (IVD) as a field really started to take shape from late 20th century. Significant investments and research have been funnelled into early diagnosis of cancer with new products including next-generation sequencing, liquid biopsy and companion diagnostics, whilst payers are increasingly demanding biomarker stratification to justify the use of expensive drugs. Time and time again, the healthcare industry is buzzing with new ideas on how to use next generation diagnostics to achieve “smart healthcare,” but to date, this has not been realised. Yet, the unmet needs remain with ballooning healthcare cost, aging society and changes in disease trends.

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