News and press releases
SKY92 Gene Signature Facilitates Cost-effective, Risk-stratified Treatment of Multiple Myeloma
SKY92 Gene Signature Facilitates Cost-effective, Risk-stratified Treatment of
Poster Presentation at ISPOR European Congress Demonstrates Cost-savings and Health-Generating Benefits of SKY92
Rotterdam, the Netherlands and Laguna Hills, CA, November 13, 2017 – SkylineDx announced new data from the 20th Annual European Congress of the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) in Glasgow, Scotland, that demonstrate the cost-savings and health-generating potential of MMprofiler™ with SKY92, the company’s prognostic tool to risk-stratify patients with multiple myeloma (MM). This is the first study to examine the potential health economic value of risk-stratified treatment (RST) in MM within the European Union (EU).
“Despite a general trend toward increasing survival, treatment outcomes in multiple myeloma remain highly variable, making risk stratification an essential component of therapeutic decision-making,” said Jennifer G. Gaultney, PhD, Senior Health Economics Consultant at IQVIA in London, UK. “The SKY92 gene signature is the most reliable prognostic biomarker in multiple myeloma for prediction of high risk patients with expected survival of less than two years, and its use appears to facilitate both cost-effective and outcomes-enhancing treatment of this devastating disease.”
At the ISPOR Congress, Dr. Gaultney and colleagues presented a poster summarizing their cost-effectiveness analysis of data from the Phase III HOVON 65/GMMG-HD4 clinical trial. The analysis evaluated two different scenarios: one in which all patients are treated the same (uniform treatment, or UT), and one that uses a RST approach based on one or more risk biomarkers.
The investigators developed a decision analytic model that simulated the total costs and health benefits of UT versus RST for three risk categories: high risk, standard risk, and unknown risk (i.e., data were not available for one or more prognostic factors). For each country included in the analysis (the Netherlands, Germany, UK, France, and Spain), all RST scenarios dominated UT, with RST-SKY92 producing the greatest health gains compared to UT. In terms of cost-effectiveness, the greatest benefits of RST compared to UT were demonstrated in Germany and France.
“The data presented at ISPOR show how SKY92 facilitates early assessment of the circumstances under which risk-stratified treatment is beneficial in newly diagnosed patients with multiple myeloma,” commented Dharminder S. Chahal, Chief Executive Officer of SkylineDx. “Although the data are specific to Europe, they are potentially transferable to other geographic areas, and support the rationale for risk-stratified therapeutic approaches in multiple myeloma.”
About Multiple Myeloma
Multiple myeloma (MM) is a cancer that arises from plasma cells, a type of white blood cell made in the bone marrow. In patients with MM, the plasma cells become abnormal, multiply uncontrollably, and release only one type of antibody – known as M-protein – which has no useful function. According to the World Cancer Research Fund International, an estimated 114,000 people around the world are diagnosed with MM annually, and the disease represents 0.8% of all cancers globally.
For more information about MM, visit www.hematon.nl/myeloom (information available in Dutch only), www.themmrf.org, www.myeloma.org.uk, www.mpeurope.org, or www.myeloma.org.
About MMprofiler with SKY92
MMprofiler assesses risk by measuring the activity of 92 MM-related genes that comprise
SKY92, SkylineDx’s novel, prognostic gene classifier. The lead product of SkylineDx,
MMprofiler is proven to be superior to the biomarkers currently used to risk-stratify newly
diagnosed and relapsed multiple myeloma patients into a “high” or “standard” risk category.1
Included in a growing number of international treatment guidelines, MMprofiler is CE-IVD
registered in Europe and will be coming soon as a laboratory-developed test (LDT) in the
United States. For more information, please visit www.mmprofiler.com.
SkylineDx is a commercial-stage biotech company based in Rotterdam, the Netherlands.
Originally a spin-off of the Erasmus Medical Center in Rotterdam, the company specializes in
the development and marketing of innovative gene signature-based prognostic tests to assist
healthcare professionals in making personalized treatment decisions for individual patients.
These tests are designed to accurately determine the type or status of the disease or to
predict a patient’s response to a specific treatment. Based on the test results, healthcare
professionals can tailor the treatment to the individual patient. MMprofiler with SKY92 is the
company’s lead product. To learn more, please visit www.skylinedx.com.
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Media Inquiries for SkylineDx
Jeffrey Jones, SkylineDx
1 Van Beers EH, van Vliet M, de Best L, et al. SKY92 GEP, iFISH, and ISS comparisons for risk stratification in multiple
myeloma. Poster p661 presented at 20th European Hematology Association Congress, Vienna, Austria, June 13, 2015.
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- SKY92 Gene Signature Facilitates Cost-effective, Risk-stratified Treatment of Multiple Myeloma
- SkylineDx Announces Prognostic Tool to be Used as Part of Major New Myeloma Clinical Trial
- SkylineDx Researchers Publish Data Demonstrating Utility of SKY92 as Prognostic Tool in Multiple Myeloma (MM)
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- SkylineDx Announces Multiple Studies Being Presented at the 58th Annual ASH Meeting Reinforcing Utility of MMprofiler™ Gene-Based Prognostic Signature to Impact Treatment of Patients with Multiple Myeloma
- SkylineDx Receives Notice of Allowance to Grant Patent for Prognostic SKY92 Gene Signature in Japan
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- SkylineDx Receives CE-IVD Mark for MMprofiler™ Its Innovative Gene Signature-Based Test for Multiple Myeloma
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13 Sep 2017 - 16 Sep 2017, Houston, TX, USA
Society of Hematologic Oncology - 2017 Annual Meeting
SkylineDx will be represented at the SOHO Annual Meeting by Lindsay Kelly, Field Application Specialist..
26 Sep 2017 - 26 Sep 2017, Prague, Czech Republic
Translational Medicine '17
At Translation Medicine '17, Dharminder Chahal, CEO of SkylineDx, will be leading Workshop A: Translating biomarkers into in-vitro diagnostics.
04 Oct 2017 - 05 Oct 2017, Maison du Savoir at Campus Belval, Luxembourg
4th International Systems Biomedicine Symposium: Impact of big data analytics on healthcare
SkylineDx will be represented at this symposium by Martin van Vliet, EVP Bioinformatics and Product Development.
06 Oct 2017 - 07 Oct 2017, San Francisco, CA, USA
NCCN 11th Annual Congress: Hematologic Malignancies
SkylineDx will be represented at the NCCN 11th Annual Congress: Hematologic Malignancies by Patricia Murphy, Regional Business Manager, The Americas, and Rosanna Santos, Global Product Manager.
26 Oct 2017 - 27 Oct 2017, Porto, Portugal
Biotech Pharma Summit
SkylineDx EVP of Commercial Operations, Jeffrey Jones, will give a presentation related to overcoming challenges in the global commercialization of novel biomarkers at the Biotech Pharma Summit.
04 Nov 2017 - 08 Nov 2017, Glasgow, Scotland
International Society for Pharmacoeconomics & Outcomes Research (ISPOR) 20th Annual European Congress
SkylineDx will be represented at this conference by Jennifer Gaultney, PhD, MPH with Mapi, who will give a health economics presentation related to MMprofiler with SKY92.
09 Nov 2017 - 10 Nov 2017, Leiden, The Netherlands
6th European Scientific Foundation of Laboratory Hemato Oncology (ESLHO) Symposium on
SkylineDx will be represented at this ESLHO meeting by Erik van Beers, VP, Genomics, and Jolien van Leijen, Account Manager, Benelux.
16 Nov 2017 - 18 Nov 2017, Salt Lake City, Utah, USA
Association for Molecular Pathology (AMP) Global Congress on Molecular Pathology
SkylineDx will be represented at the AMP Global Congress on Molecular Pathology by Lindsay Kelly, Field Application Specialist.
22 Nov 2017 - 22 Nov 2017, Oss, The Netherlands
Dutch Life Sciences Conference
At the 13th edition of the Dutch Life Sciences conference, Dharminder Chahal, CEO of SkylineDx, will be speaking on early stage diagnostics in healthcare.
09 Dec 2017 - 12 Dec 2017, Atlanta, GA, USA
American Society of Hematology - 59th Annual Meeting & Exposition
SkylineDx will be represented at the ASH 59th Annual Meeting by the Executive, Commercial, Business Development and Operations teams. Please visit us at the SkylineDx booth # 2047;