SkylineDx has published a new study marking a “significant advancement” in the understanding and identification of high-risk (HR) multiple myeloma (MM) patients.
The Dutch company’s prospective real-world evidence study of 109 newly diagnosed MM patients and 149 with relapsed/refractory MM (r/r MM) combined its MMprofiler with SKY92 gene expression profiling in vitro diagnostic (IVD) with fluorescence in situ hybridisation (FISH) testing.
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SKY92 measures the activity of 92 genes in the malignant myeloma plasma cells to quantify how aggressive a myeloma is while FISH looks for gene changes in cells per the Second Revised International Staging System (R2-ISS) for risk quantification.
By combining the diagnostic approaches, the study found that patients with HR profiles were more accurately identified than with FISH alone.
According to the study author Martin Kortüm, senior physician at the University Hospital of Würzburg, SkylineDx’s SKY92 test has proven to be an “invaluable tool” in assessing individual patient risk and is particularly effective in identifying HR MM cases that remain undetected by FISH.
Identification of myeloma as high-risk is important because it means that it is less likely to respond to conventional treatments, and often indicates that a patient may benefit from intensification of therapy beyond clinicians’ first-line interventions in the treatment approach.
SkyLineDx chief scientific officer Jvalini Dwarkasing commented: “By combining SKY92 with FISH, we are not only enhancing our ability to identify high-risk MM patients but also paving the way for more targeted and effective treatment plans.”
While MM is a rarer cancer, affecting around one in 103 men and one in 131 women in the US, the American Cancer Society (ACS) forecasts that in 2025, around 36,110 new cases of MM will be diagnosed, among more in men than women, and with around 12,000 overall deaths expected to occur. The risk of developing MM goes up as people get older and most people diagnosed with the cancer are at least 65 years old.
In 2024, SkylineDx announced that it had validated Merlin, its Clinical-Pathologic and Gene Expression Profile (CP-GEP) test for the identification of sentinel lymph node biopsy (SLNB) status in high-risk cutaneous melanoma patients.
