MMprofiler Comprehensive Assay for Genetic Subtyping of Multiple Myeloma A Powerful Tool for Patient Stratification Now available GEP ‘high risk’ stratification Currently for Research Use Only MMprofiler: Comprehensive Subtyping of Multiple Myeloma MMprofiler is a unique and comprehensive assay for genetic subtyping of patients with the heterogeneous disease multiple myeloma (MM). The test is the most powerful tool available for this type of patient stratification. MMprofiler is the only all-in-one test that combines the use of innovative signatures like the SKY92 and more traditional genetic markers. The microarray-based assay helps to improve the success rate of clinical research and drug development. The MMprofiler ■■ ■■ ■■ Can be used in your own lab, but is also available as a full research service through the SkylineDx laboratory Allows for retrospective data analysis in order to obtain new insights from clinical data Is already being used for stratified efficacy assessment, for example in retrospective analyses All-in-one Genetic Subtyping MMprofiler is a unique and standardized test that combines novel signatures like the SKY92 and more traditional genetic markers for example for stratified drug efficacy assessment, including: Prognostic gene signature SKY92 Gene expression markers E.g. CRBN expression Cytogenetic markers t(4;14) t(11;14) t(14;16) / t(14;20) del1p add1q del13 (mono13) del17p H-MM (add9) Gene expression clusters MS cluster MF cluster NFKB cluster Custom data analysis Genome wide expression data SKY92: Superior GEP Signature The SKY92 Gene Expression Profiling (GEP) marker: ■■ Is superior over FISH markers and other GEP risk signatures ■■ Finds that ~20% of MM patients are SKY92 ‘high risk’ patients ■■ Detects a 4.4 times shorter survival in SKY92 ‘high risk’ patients ■■ Identifies a unique patient group with unmet medical needs ■■ Has been reproduced in 5 independent cohorts Increase the Impact of Your Clinical Research Cumulative survival MMprofiler increases the impact of your clinical research by allowing to: ■■ Find the patients that benefit most from a novel treatment ■■ Find the most effective drug for MM patients ■■ Cross-correlate world-wide clinical trial data MM patients MMprofiler Responders ✔ ✘ Control Non-responders Control Time Stratification Improve the Chances of Success of Your Drug Development MMprofiler improves cost-efficiency and chances of success of your multiple myeloma drug development by performing the most powerful genetic patient subtyping and comprehensive data gathering. The test helps to: ■■ Find and target the true responders ■■ Show stronger efficacy in the right population ■■ Do smaller and less expensive trials ■■ Increase drug approval success rate ■■ Shorten the time to market ■■ Prolong your patent position ■■ Improve the reimbursement level Future Use of MMprofiler MMprofiler is being developed as an approved diagnostic test in Europe and the U.S.A. Research Use Only Now available Diagnostic service 2014 IVD kit 2015 This will result in: ■■ Improved prognostics of MM patients ■■ Use of patient stratification for treatment decision making ■■ More effective drug use ■■ Increased quality of life ■■ Decreased treatment costs SkylineDx BV SkylineDx develops and markets array-based diagnostic tests using gene signatures for personalized medicine in oncology. The company offers a unique set of efficient and comprehensive genetic testing tools and services for stratification of patient groups with multiple myeloma, acute myeloid leukemia and other diseases. As an innovative company, SkylineDx is continuously seeking academic and industrial partners for development of novel diagnostic products. Products and Services In addition to the MMprofiler, SkylineDx offers the following products and services. ■■ ■■ ■■ AMLprofiler: Fast Diagnostic and Prognostic Test for AML AMLprofiler is a fast, robust and standardized diagnostic test for acute myeloid leukemia available on the European market (CE IVD kit) for risk stratification and genetic subtyping leading to treatment decisions regarding individual patients. The test is available in the United States for research use only. Biomarker Discovery: Find the Marker That Truly Matters By means of its unique genetic subtyping assays as well as its genome wide biomarker discovery bioinformatics services, SkylineDx is able to link drug effectiveness to patient subgroups. In addition to application in drug development, registration and marketing, our services may provide an opportunity to revive drugs that may not have been proven successful in past trials. Companion Diagnostic Development: We Take Care With our translational, regulatory and quality management expertise for both the European as well as US market, SkylineDx has the ability to develop established biomarkers into regulatory compliant companion diagnostics. References All references can be found on our website: www.skylinedx.com/references The Markers That Matter. The Decision That Counts. SkylineDx BV Rotterdam Science Tower Marconistraat 16, 18th floor 3029 AK Rotterdam The Netherlands www.skylinedx.com [email protected] +31 (0)10 70 38 410