ROTTERDAM, the Netherlands and SAN DIEGO, Dec. 7, 2024 /PRNewswire/ -- SkylineDx, an innovative diagnostics company specializing in the research and development of molecular diagnostics for oncology, inflammatory, and infectious diseases, announce that groundbreaking data on the Prognostic Value of the SKY92 Classifier over High-Risk Cytogenetic Aberrations in Multiple Myeloma will be presented during the upcoming American Society of Hematology (ASH) conference. The results were obtained from the PROMMIS real-world study, conducted in nine academic cancer centers across the United States. The presentation, led by Dr. Noa Biran, Associate Professor at Hackensack Meridian School of Medicine, highlights the significant impact of SKY92 on risk stratification in multiple myeloma patients.

Multiple myeloma is a hematological malignancy characterized by a complex molecular landscape. Despite advancements in modern therapies, a subset of patients classified as high-risk continues to experience poor survival outcomes. Traditional risk stratification relies heavily on identifying cytogenetic aberrations. However, the PROMMIS study provides compelling evidence that the SKY92 gene expression profiling (GEP) classifier offers crucial biological insight and independent prognostic value.

The study [1] included 251 newly diagnosed multiple myeloma patients that were follow up for over nearly four years to monitor their progression. The results showed that individual chromosomal abnormalities and their co-occurrence had limited prognostic value, with the sole exception of the 1q21 abnormality, which prognostic significance for PFS was exclusive to patients aged 65 years and older. SKY92 proved to be a much stronger predictor of poor outcomes. Patients that had the high-risk biomarker SKY92 had significantly worse progression-free survival rates, regardless of whether they had other genetic abnormalities.

The research also showed that combining SKY92 results with specific genetic markers like gain(1q21) could offer even more detailed insights. For example, patients flagged as high-risk by both tests had some of the poorest outcomes, underlining the complementary value of using SKY92.

Dr. Jvalini Dwarkasing, Chief Scientific Officer at SkylineDx, emphasized the importance of this research: "These findings highlight how the SKY92 test can make a real difference in the care of multiple myeloma patients. By offering a clearer and more reliable way to identify high-risk disease, we are giving doctors powerful tools to tailor treatments and improve outcomes. This research reinforces our commitment to advancing personalized medicine."

This study marks a significant step forward in understanding and treating multiple myeloma. The SKY92 test not only provides a more accurate way to identify high-risk disease but also helps refine how we use existing genetic information. By integrating this advanced technology into routine care, clinicians can better support patients facing this challenging disease.

SkylineDx is grateful to the patients, doctors, and research teams who contributed to the PROMMIS study, which would not have been possible without their dedication.

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. Brian et al. Enhanced Prognostic Value of the SKY92 Classifier over High-Risk Cytogenetic Aberrations in Multiple Myeloma: Results from the Prommis Real-World Study
   Paper: Enhanced Prognostic Value of the SKY92 Classifier over High-Risk Cytogenetic Aberrations in Multiple Myeloma: Results from the Prommis Real-World Study

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SOURCE SkylineDx