ROTTERDAM (the Netherlands), SAN DIEGO (CA, USA), December 8th 2023: – SkylineDx, an innovative diagnostics company focused on research & development of molecular diagnostics is looking forward to the release of new data during the American Society of Hematology (ASH) 2023 Annual Meeting. Dr. Noa Biran, Associate Professor at Hackensack Meridian School of Medicine, will present two posters from the pioneering US study on risk assessment in multiple myeloma. These studies were conducted within the PRospective Observational Multiple Myeloma Impact Study (PROMMIS; NCT02911571) trial, which aim to assess the impact of SKY92 on risk stratification and treatment decisions in clinical practice for newly diagnosed multiple myeloma patients.
Multiple Myeloma (MM) is a complex hematologic malignancy marked by genetic instability, variable survival rates, and diverse treatment responses. The SKY92 gene expression profiling (GEP) assay is a valuable tool for stratifying MM patients into high-risk and standard-risk groups for disease progression and survival. Despite advances in MM treatments, a subset of high-risk patients still faces limited benefits from current therapies. This study aims to assess risk classification based on conventional risk markers and the SKY92 risk classifier, providing insights for optimizing risk-adapted treatment.
A total of 251 MM patients were enrolled in this prospective US multicenter trial. The results based on prospective real-world clinical data show significant differences in progression-free survival (PFS) and overall survival (OS) between SKY92 standard-risk and high-risk patients, confirming SKY92’s reliability as a prognostic marker.
Integrating R-ISS staging with SKY92 classification, as previously reported [Kuiper et al. 2020], resulted in three risk groups. This combined classification method identified a larger number of high-risk patients with a significantly shorter OS and PFS when compared to the R-ISS alone.
The trial results reveal a significant discrepancy between risk stratification derived from conventional clinical practice assessments and that determined by SKY92. Integration of SKY92 into clinical practice enables the identification of a subset of high-risk patients characterized by substantially shorter PFS and OS. These findings support the added value of integrating SKY92 into clinical practice for precise risk assessment of patients. Furthermore, the integration of SKY92 resulted in increased physician confidence in assessing patient risks.
Jvalini Dwarkasing, Chief Scientific Officer of SkylineDx, expressed the company’s enthusiasm for these presentations, saying, “At SkylineDx, our mission is to advance the field of hematological diagnostics and ultimately improve patient care. We are proud that Dr. Biran will be presenting the insights from these groundbreaking studies that have the potential to transform the way we understand and treat hematologic disorders.”
Dr. Noa Biran’s presentations at ASH 2023 promise to challenge risk stratification in multiple myeloma, with implications for personalized treatment approaches and improved patient outcomes.1-2
About SkylineDx
SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology and inflammatory diseases. SkylineDx uses its expertise to bridge the gap between academically discovered gene expression signatures and commercially available diagnostic products with high clinical utility, assisting healthcare professionals in accurately determining the type or status of disease or predicting a patient’s response to treatment. Based on test results, healthcare professionals can tailor the treatment approach to the individual patient. SkylineDx is headquartered in Rotterdam. the Netherlands, complemented by a U.S. base of operations and a CAP/CLIA certified laboratory in San Diego California, USA. To learn more about SkylineDx, please visit www.skylinedx.com.
Footnotes:
- Unveiling the Discrepancy in Multiple Myeloma Risk Classification between Clinical Practice and SKY92 Test and the Impact on Survival (confex.com)Paper: Unveiling the Discrepancy in Multiple Myeloma Risk Classification between Clinical Practice and SKY92 Test and the Impact on Survival (confex.com)
- Prommis Trial Prospectively Demonstrates the Efficacy of SKY92 Risk Stratification in Newly Diagnosed Multiple Myeloma Patients (confex.com)
