Superior risk identification for newly diagnosed multiple myeloma patients
The MMprofiler™ is our lead product. The MMprofiler™ is a prognostic test to determine the level of risk of a multiple myeloma (MM, bone marrow cancer) patient by classifying such patient into a “high” or “standard” risk group. Patients with a “high” risk classification have a poor prognosis i.e. relatively short expected overall survival, as compared to patients with a standard risk profile, regardless of treatment. Additionally, these “high risk” patients relapse faster. Unfortunately, approximately 15-25% of newly-diagnosed multiple myeloma patients belong to the high risk group and The MMprofiler™ can assist healthcare professionals in choosing the most appropriate treatment based on the patient’s risk classification, while avoiding treatments that may be less beneficial, unnecessarily costly or harmful.
With the MMprofiler™, it is made possible to predict the disease progress based on the genetic properties of the malignant cell. While the current methods accommodate this need to some extent, it makes more sense to mark all genes involved in the incidence of multiple myeloma at once and through more reliable methods. The MMprofiler™ measures the activity of 92 genes (SKY92 gene profile) which are directly or indirectly related to the disease. The MMprofiler™ test is a fully validated test that is executed by the diagnostic laboratory technicians following a step-by step standardized instructions for use (IFU). The genetic data analysis process if fully validated and automated and run on our proprietary Profiler™ platform, a fully secured, centralized data analysis system for complex genetic diagnostic tests. A report with the interpreted genetic data is returned to the lab within 15 minutes.
These measurements have been repeated across different studies, always with the same robustness and predictable outcome, thereby creating a test that is more reliable than traditional methods. Based on the profile generated, the healthcare professional can determine the most optimal treatment for his/her patients, with the goal to personalize treatment and prevent over or under treatment.
Several guidelines for the treatment of multiple myeloma, like mSMART guidelines, recommend that patients be treated in accordance with their prognosis. Patients, patient advocacy organizations, healthcare professionals and clinical geneticists have all expressed a strong interest in this new test.
SKY92 Gene Expression Profile
Researchers at the Erasmus Medical Centre published a paper in Leukemia in 2012, describing a newly discovered genetic subtype in multiple myeloma, which is key to the risk profile of the patient. This gene expression profile, which maps the activity of 92 genes (pieces of genetic material) is called ‘EMC92’ in the scientific publications and is now named ‘SKY92’ being part of the MMprofiler™ test. The chance of long-term survival as well as the time to progression of the disease in patients with multiple myeloma was found to correlate with the activity of these 92 genes.
Plasma cells with SKY92 positive expression levels are associated with a poorer prognosis and a faster progression (relapse) of the disease and this is considered a high risk profile. In contrast, patients who are SKY92 negative have a standard risk profile.