The MMproﬁler is a diagnostic gene expression based microarray assay - currently used as research
use only - developed by SkylineDx. The MMproﬁler currently contains multiple markers and has the
potential to classify patients with Multiple Myeloma (MM) - a rather rare and incurable blood cancer - into a high risk (poor prognosis) or a low risk (standard prognosis) group.
In 2014, globally, approximately 109,300 newly diagnosed patients face a process of pharmacological
treatment. Cancer treatment is only in 30% of the cases effective and with the more and more
pharmacological treatments for MM approved or in development, it is essential to stratify patients
during diagnosis in order to provide the best possible pharmacological treatment Unfortunately,
currently available diagnostic tests for MM are not able to stratify the patient. By not stratifying prior to treatment a low risk patient often faces overtreatment and a high risk patient treatments based on trial and error.
With the MMproﬁler we are potentially not only able to stratify a patient into a low risk or a high risk
group but to actually assign a patient to a specific pharmacological treatment With the MMproﬁler the clinician is basically a step closer to personalized treatment, saving a great cause of harm for the
patient while at the same time reducing health care costs dramatically. The success of the MMproﬁler depends on its biomarkers. The validation of these biomarkers, before market access is granted, requires substantial investments. This feasibility study will be essential to decide whether to further develop and validate del17 as an IVD biomarker on our MMproﬁler assay.