SKYLINEDX ANNOUNCES NEW PUBLICATION ON SKY92 GENE EXPRESSION PROFILING TEST in DEFINING ULTRA-HIGH-RISK MULTIPLE MYELOMA

ROTTERDAM, the Netherlands and SAN DIEGO, Feb. 28, 2025 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, and inflammatory and infectious diseases, announces the publication of groundbreaking research titled "Combining SKY92 gene expression profiling and FISH (according to R2-ISS) defines ultra-high-risk Multiple Myeloma."[1]. This study marks a significant advancement in the understanding and identification of ultra-high-risk multiple myeloma patients.

This recent study underscores the prognostic significance of the SKY92 gene expression profiling test in both newly diagnosed (NDMM) and relapsed/refractory multiple myeloma (RRMM) patients in routine clinical practice. Conducted as a prospective real-world evidence study,the research highlights the synergistic potential of integrating SKY92 with fluorescence in situ hybridization (FISH) according to the Second Revised International Staging System (R2-ISS). The study identified discrepancies between existing risk classification systems, revealing that the combination of SKY92 and FISH enables a more precise stratification of multiple myeloma patients.

This combined approach allows clinicians to more accurately identify patients with ultra-high-risk profiles, paving the way for improved risk-adapted treatment strategies. These findings reinforce the value of SKY92 as a critical tool in the evolving landscape of multiple myeloma prognostication and personalized treatment planning.

"In my clinical practice, the SKY92 test has proven to be an invaluable tool for assessing individual patient risk. It has been particularly effective in identifying high-risk multiple myeloma cases that remain undetected by FISH, as well as in recognizing patients with distinct ultra-high-risk characteristics," said Professor Martin, Kortüm, last author of the study and senior physician at the University Hospital of Würzburg. His study team treated all study participants, including 109 with NDMM and 149 with RRMM.

"We are incredibly proud of this publication and the collaborative effort that led to these important findings," added Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx. "By combining SKY92 with FISH, we are not only enhancing our ability to identify high-risk multiple myeloma patients but also paving the way for more targeted and effective treatment plans. This research underscores our commitment to advancing precision medicine and improving the lives of patients affected by this challenging disease."

SkylineDx is excited to share this new data with the medical community and looks forward to the continued exploration of innovative diagnostic tools that can transform patient care.

About MMprofiler with SKY92
Multiple Myeloma is a heterogeneous disease and its course can vary significantly between patients. MMprofiler with the SKY92 biomarker enhances the biological insights into the diseases. This molecular diagnostic test measures the activity of 92 genes in the malignant myeloma plasma cells, and determines how aggressive the myeloma is. When myeloma is more aggressive (high-risk disease) it is less likely to respond to conventional treatments and the patient might benefit from intensification of therapy. MMprofiler with SKY92 is CE-IVD registered in Europe and available as laboratory developed test (LDT) from SkylineDx's CAP/CLIA lab in San Diego (CA, USA).

About SkylineDx
SkylineDx is a biotechnology company focused on research & development of molecular diagnostics in oncology inflammatory, and infectious 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:

1. Zhou et al. Combining SKY92 gene expression profiling and FISH (according to R2-ISS) defines ultra-high-risk Multiple Myeloma. Combining SKY92 gene expression profiling and FISH (according to R2–ISS) defines ultra–high–risk Multiple Myeloma - Zhou - 2025 - HemaSphere - Wiley Online Library