Biomarkers can be objectively measured and evaluated as indicators of normal or pathogenic biological processes or of pharmacologic response to therapeutic interventions. As such biomarkers hold great potential to predict clinical outcomes and define a personalised treatment strategy. Given the complexity of the neoplastic process, in most instances a single marker cannot offer the necessary sensitivity and specificity. Therefore research is now focussed on the development of multiplexed assays that screen multiple genes and proteins at the same time.
Regulatory challenges, the hurdles to achieve reimbursement, and access to clinical data are all barriers that will need to be further addressed by all stakeholders to achieve widespread use of biomarkers in clinical practice in future.
Health Technology Assessment (HTA) and patient access
From the healthcare system perspective, access to biomarkers that define the patients that may or may not respond to therapy will be crucial to improve treatment standards and efficiency of care.
The Way ahead
The close collaboration between the Cancer Drug Development Forum (CDDF) and the European Cancer Patient Coalition (ECPC) aims to raise awareness and educate patients/policy makers regarding biomarkers and personalised medicine. Biomarker testing holds value for facilitating faster diagnosis, a targeted personalised treatment plan, and avoid wasting resources on ineffective treatments.
For more information about the Personalised Medicine Awareness Month 2018 and to download the Campaign Action Toolkit, available in 12 languages, please visit: ecpc.org//personalisedmedicine2018