Precision in health care

Precision medicine and monoclonal antibodies: breach of promise?

“…The European public assessment reports for half of the 26 approved anti-cancer mABs do not list a biomarker (13) (Table 1). Biomarkers are reported more frequently for the mABs approved for solid tumors (14), which are slightly more numerous than those for blood cancers (12) – the latter being more curable than the former for a long time with small molecules. Of the nine biomarkers reported, all but one (Philadelphia chromosome) are proteins, and the only companion tests explicitly written in all the European reports are still those for detecting the biomarkers of the two “pioneer” targeted mABs (3).…”

“…Focused on biology rather than on other variables, such as lifestyle or environment, PM presents itself as the ultimate science, and its full promise goes even beyond targeting therapies for patients (14) and includes the ability to identify healthy individuals at high risk and take preventive measures for them (15). The PM’s basic assumption is that genetics is the underlying factor in most health conditions, so diseases are mainly affected by the human genetic make-up (16).…”

“…Critics argue that PM is continuously fueling unrealistic expectations, distracting funds from tackling widespread risk factors such as smoking, alcoholism, and obesity (5). Although it is well known that many diseases stem from unhealthy lifestyles and socio-economic conditions (22), researchers’ ambitions and media channels relentlessly foster the arguable PM promises, and keep attracting big funding (14). However, PM advocates would do better to temper their narrative of radical change and communicate a more realistic set of expectations through the media to the public (5), in line with the incremental nature of science.…”

Public R&D Projects-Based Investment and Collaboration Framework for an Overarching South Korean National Strategy of Personalized Medicine

“…Thus, the United States Precision Medicine Initiative and the European Union's (EU's) "Personalised Medicine" (PerMed) were announced in 2015, and the International Consortium for Personalised Medicine (ICPerMed) was announced in 2016 [2][3][4][5][6]. The US Precision Medicine Initiative is a long-term research endeavor to develop a new model of individualized care with a USD 9269 million investment from 2016 to 2020 [7,8] while PerMed and ICPerMed focused on coordinating and fostering research to develop and evaluate PM approaches at the European and international levels with EUR 3.2 billion spent during 2007-2020. After these announcements, other governments, including South Korea, Japan, and China, set out their national PM strategies.…”

Gene Expression Profiling of FFPE Samples: A Titration Test

“…The rapid advancement of genomic technologies over the past decades has led to individualized diagnostic and therapeutic approaches, allowing the implementation of precision medicine. 1 – 4 Yet, the histological assessment remains the “gold standard” for pathology diagnostics, 5 despite the lack of reproducibility due to the subjective interpretation of the histopathologists. Molecular technologies can help overcome arbitrary histological interpretation; however, their application has been so far limited by the cost and by the technical challenges that can arise when working with archival samples, such as formalin-fixed paraffin-embedded (FFPE) samples.…”