Recommendations tumor-biomarker diagnostics

Posted on 05-09-2013

A large group of scientists, representing the diagnostics industry, insurance payers, and clinical oncologists has recently published a set of recommendations they believe would accelerate the development of clinically useful tests to personalize cancer therapy. 

These recommendations are completely in line with Fournier-Majoie Foundation‘s mission and help to understand why and how our Foundation focuses on cancer biomarker development. According to the authors, a “vicious cycle” has prevented widespread adoption of robust cancer biomarker tests. Regulatory inconsistencies, poor reimbursement levels, insufficient investment in the research and development of clinical utility evidence based tests: each of these elements reinforce each other in a feed-back loop resulting in the lack of reliable tests used in clinical practice. Thus, tumor-biomarkerbased test development and adoption into clinical practice has lagged far behind advances in cancer therapy even though biomarker tests are as critical for patient care as therapeutic agents.

Why are tumor-biomarkers tests critical?

The authors remind us what impact biomarkers can have. Biomarkers may deliver better health outcomes to the patient and help decrease health-care costs. They may provide earlier diagnosis, more accurate prognosis and indication of whether a cancer patient is likely to benefit from a given treatment or not. They may prevent administration of futile treatment by identifying the patients that will not benefit from it while ensuring that those most likely to benefit are treated efficiently.

Focusing on clinical utility should break the vicious cycle.

The authors give us a road map with five recommendations to facilitate the development of useful diagnostics tests. Their main advice is that each of the following actors; regulators, reimbursement institutions, peer-reviewed publication policy makers, investigators and R&D entrepreneurs, should focus more on gathering evidence for clinical utility (on wether the results of the test provide information that contributes to and improves current optimal management of the patient's disease) which was, until now, frequently neglected. By doing so, each stakeholder would increase the value of  tumor biomarker tests  and shift the vicious cycle into a virtuous one.

Foundation Fournier-Majoie: moving tumor-biomarkers tests forward

Our foundation highly values the generation of useful diagnostic tests. We run focus groups with physicians to gather a clear view on current clinical practice and to identify real medical needs for the products we develop.  We organize trainings with particular emphasis on health-economics and the clinical utility of biomarker based tests (this will be topic again of our 2014 Friends Day - to be announced soon).

We offer  researchers not only adequate funding/investment but also share the expertise of our staff and network. As such, our foundation can "make the difference" by enhancing capabilities of our grantees. Concretely, Fournier-Majoie Foundation follows the project teams as much as needed through "joint steering committees" and ad hoc coaching.
 

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