Nuclear theranostics in Asia; In vivo companion diagnostics

Personalized medicine is the core concept of modern medicine and whatever it is called in any newly coined names, it manifests that medicine is practiced in a customized way to help individual persons in any phase of medical intervention such as prevention, classification and prognostic characterization (diagnosis), therapy and rehabilitation/regeneration. The most instrumental among these interventions is therapy which should be obviously personalized. Novel therapy for inhibition of immune checkpoint with monoclonal antibodies were phenomenally successful [1] in treating some (less than 20%) susceptible patients (with melanoma) and raised immediately the importance of in vitro companion diagnostics. In 2016, Food and Drug Administration (FDA) of the USA published a document "Principles for codevelopment of an in vitro companion diagnostic device with a therapeutic product" which mandates the development of in vitro diagnostic (IVD) companion diagnostic devices contemporaneously with the approval of the novel therapeutic products [2]. This is also adopted by other countries, for example, Korea in its publication of similar announcement in 2018 as "Guideline for approval of medicines associated with companion diagnostic devices" by Korean Ministry of Food and Drug Safety [3]. In the USA, 35 novel therapeutic products as new drug application (NDA) or biologic license application (BLA) were approved as companion diagnostics as of December 6, of 2018 [4]. What is interesting is that FDA defined a companion diagnostic as in vitro diagnostic device or an imaging tool to prove safe and effective use of companion therapeutic products. Here the term "effective' means that companion diagnostic devices can discern whether the companion therapeutic product will take effect on the patients