TEST:

SKY92 Test

Our results support more comprehensive baseline diagnostic profiling to identify those at risk of ER upfront. ISRCTN49407852, NCT01554852.

"SkylineDx...announces the publication of new results from the PRospective Observational Multiple Myeloma Impact Study (PROMMIS) in the British Journal of Haematology [1]. The paper prospectively validates SKY92’s prognostic performance using real-world data and assesses its impact on risk classification and (hypothetical) treatment decisions compared to conventional markers. This prospective, real-world study reinforces the clinical utility of the SKY92 gene expression profiling (GEP) classifier in improving risk stratification and guiding treatment decisions in multiple myeloma (MM) patient care."

P1/2, N=142, Active, not recruiting, SWOG Cancer Research Network | Trial completion date: Mar 2025 --> Dec 2025

Unblinding SKY92 results led to hypothetical treatment revisions for 50% of patients (p < 0.001) and increased physicians' confidence in treatment decisions for 40% of cases. These findings support SKY92's prognostic value in identifying high-risk MM patients, outperforming traditional risk markers and demonstrating the potential added value of its integration into clinical practice for more personalized risk assessment.

"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."

Additionally, whole genome sequencing (WGS) revealed CRBN mutation (n = 3) and bi-allelic events (mutation and/or deletion) in TP53 (n = 7) and TNFRSF17 (n = 1). Altogether, we provide the first prospective real-world evidence that the combination SKY92 and FISH (according to R2-ISS) identifies a subset of patients with ultra-HR MM, and WGS complements SKY92 and FISH in MM risk stratification.

"SkylineDx...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 significant impact of SKY92 on risk stratification in multiple myeloma patients...Patients that had the high-risk biomarker SKY92 had significantly worse progression-free survival rates, regardless of whether they had other genetic abnormalities."

"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."