25 juli 2019: zie ook dit artikel: 

https://kanker-actueel.nl/genentest-blijkt-voorspellende-waarde-te-hebben-bij-het-verloop-van-multiple-myeloma-ziekte-van-kahler.html

28 juli 2017: Bron: Skyline en Elsevier: https://doi.org/10.1016/j.clml.2017.06.020

Sky92, een genentest van het Nederlandse bedrijf Skyline toont opnieuw aan in een studie bij patienten met Meyloma - ziekte van Kahler, dat deze genentest goed gebruikt kan worden als prognose van de ziekte en de behandelingen. Zie ook in gerelateerde artikelen andere publicaties van de verschillende genentesten van Skyline.

Persbericht en link naar studie staan onder foto:

Sky92 beeldMMprofilerbeeld van Skyline website

Dit is hun internationale persbericht gekopieerd van hun Engelstalige website:

SkylineDx Researchers Publish Data Demonstrating Utility of SKY92 as Prognostic Tool in Multiple Myeloma (MM)

Clinical Lymphoma, Myeloma and Leukemia Paper Validates Use of SKY92 and its Combination with International Staging System (ISS)

Rotterdam, the Netherlands and Laguna Hills, CA, July 25, 2017 – SkylineDx today announced the publication of new data that validate the Company’s SKY92 gene expression signature as a prognostic tool to evaluate patients with multiple myeloma (MM). In a paper published in the current issue of Clinical Lymphoma, Myeloma and Leukemia, SkylineDx researchers  substantiate SKY92 as a tool for identifying high-risk patients, as well as SKY92 combined with the International Staging System (ISS) for identifying low-risk patients.[1] The ISS  assesses two serum parameters to identify three patient groups with different prognoses. [2]

“High-risk disease is now recognized as one of the most challenging unmet needs in the treatment of multiple myeloma,” said lead author Erik H. van Beers, Ph.D., vice president of Genomics at SkylineDx. “To further optimize disease management, we need to be able to differentiate high-risk from low-risk patients, using tools that are highly accurate and yield reproducible results across different patient groups and treatments. We have demonstrated the prognostic value of SKY92 not only as a marker of high risk, but also as a marker of low risk when combined with ISS. Both validated markers may serve as the basis for the discovery of improved individualized therapies for patients with multiple myeloma.”

Dr. van Beers and colleagues compared eight risk assessment platforms to analyze gene expression data from 91 newly diagnosed, untreated patients included in an independent dataset amassed by the Multiple Myeloma Research Foundation and the Multiple Myeloma Genomics Initiative (MMRF/MMGI). The investigators used the gene expression profiling (GEP) classifiers SKY92, UAMS70, UAMS80, IFM15, HM19, Cancer Testis Antigen (CTA), Centrosome Index, and Proliferation Index to identify high-risk patients.1

Of the eight GEP classifiers, SKY92 identified the largest proportion (21%) of high-risk cases and also attained the highest Cox proportional hazard ratio (8.2) for overall survival (OS). Additionally, SKY92 high-risk cases predicted nine of the 13 (60%) deaths that occurred at 2 years and 16 of the 31 (52%) deaths at 5 years, a predictive rate that was higher than any of the other classifiers.1

Dr. van Beers and colleagues also combined the SKY92 standard-risk classifier with the ISS to identify low-risk patients in the MMRF/MMGI cohort. This combination was recently identified as an optimal and robust marker for detecting low-risk MM[– a discovery reprinted in the current issue of the Dutch Journal of Hematology.[3,4] The SKY92/ISS marker identified 42% of patients as low-risk with median OS not reached at 96 months. The low-risk classification was strongly supported by the achieved hazard ratio of 10.1

“The MMRF/MMGI dataset was not part of our previous discovery, which demonstrated that the combination of SKY92 and ISS identifies the lowest-risk patients with high accuracy and leaves the smallest proportion of patients identified as intermediate risk,” commented Dr. van Beers.  “Thus, the dataset remained available for independent validation – an important factor in the adoption of gene expression profiling tools.”

“We are pleased to have validated the SKY92/ISS low-risk marker by applying it to the well-characterized MMRF/MMGI cohort,” added co-investigator Rafael Fonseca, M.D., professor of Medicine, chair of the Department of Internal Medicine, and consultant in the Division of Hematology/Oncology at the Mayo Clinic in Scottsdale, Arizona. “Our findings further strengthen the prognostic utility of the combination marker.”

Het astudieversalg van de studie: Prognostic Validation of SKY92 and Its Combination With ISS in an Independent Cohort of Patients With Multiple Myeloma is tegen betaling in te zien.

Hier het abstract van de studie:

hen the prognostic utility of the combination marker."

Among the eight signatures, SKY92 identified the largest proportion of patients (21%) also with the highest HR (8.2). Our analysis also validated the combination SKY92/ISS for identification of three classes; low risk (42%), intermediate risk (37%) and high risk (21%). Between low risk and high risk classes the HR is >10.

Original Study

Prognostic Validation of SKY92 and Its Combination With ISS in an Independent Cohort of Patients With Multiple Myeloma

Abstract

Background

High risk and low risk multiple myeloma patients follow a very different clinical course as reflected in their PFS and OS. To be clinically useful, methodologies used to identify high and low risk disease must be validated in representative independent clinical data and available so that patients can be managed appropriately. A recent analysis has indicated that SKY92 combined with the International Staging System (ISS) identifies patients with different risk disease with high sensitivity.

Patients and Methods

Here we computed the performance of eight gene expression based classifiers SKY92, UAMS70, UAMS80, IFM15, Proliferation Index, Centrosome Index, Cancer Testis Antigen and HM19 as well as the combination of SKY92/ISS in an independent cohort of 91 newly diagnosed MM patients.

Results

The classifiers identified between 9%-21% of patients as high risk, with hazard ratios (HRs) between 1.9 and 8.2.

Conclusion

Among the eight signatures, SKY92 identified the largest proportion of patients (21%) also with the highest HR (8.2). Our analysis also validated the combination SKY92/ISS for identification of three classes; low risk (42%), intermediate risk (37%) and high risk (21%). Between low risk and high risk classes the HR is >10.


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