SkylineDx Publishes Data Demonstrating Utility of SKY92 as Prognostic Tool in MM

SkylineDx announced the publication of new data that validate the company's SKY92 gene expression signature as a prognostic tool to evaluate patients with multiple myeloma (MM). In a paper published in the current issue of Clinical Lymphoma, Myeloma and Leukemia, SkylineDx researchers substantiate SKY92 as a tool for identifying high-risk patients, as well as SKY92 combined with the International Staging System (ISS) for identifying low-risk patients. The ISS assesses two serum parameters to identify three patient groups with different prognoses.

"High-risk disease is now recognized as one of the most challenging unmet needs in the treatment of multiple myeloma," said lead author Erik H. van Beers, Ph.D., vice president of Genomics at SkylineDx. "To further optimize disease management, we need to be able to differentiate high-risk from low-risk patients, using tools that are highly accurate and yield reproducible results across different patient groups and treatments. We have demonstrated the prognostic value of SKY92 not only as a marker of high risk, but also as a marker of low risk when combined with ISS. Both validated markers may serve as the basis for the discovery of improved individualized therapies for patients with multiple myeloma."

Dr. van Beers and colleagues compared eight risk assessment platforms to analyze gene expression data from 91 newly diagnosed, untreated patients included in an independent dataset amassed by the Multiple Myeloma Research Foundation and the Multiple Myeloma Genomics Initiative (MMRF/MMGI). The investigators used the gene expression profiling (GEP) classifiers SKY92, UAMS70, UAMS80, IFM15, HM19, Cancer Testis Antigen (CTA), Centrosome Index, and Proliferation Index to identify high-risk patients.

Of the eight GEP classifiers, SKY92 identified the largest proportion (21%) of high-risk cases and also attained the highest Cox proportional hazard ratio (8.2) for overall survival (OS). Additionally, SKY92 high-risk cases predicted nine of the 13 (60%) deaths that occurred at 2 years and 16 of the 31 (52%) deaths at 5 years, a predictive rate that was higher than any of the other classifiers.1

Multiple myeloma is a cancer that arises from plasma cells, a type of white blood cell made in the bone marrow. In patients with MM, the plasma cells become abnormal, multiply uncontrollably, and release only one type of antibody – known as M-protein – which has no useful function. According to the World Cancer Research Fund International, an estimated 114,000 people around the world are diagnosed with MM annually, and the disease represents 0.8% of all cancers globally.

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