News and press releases
SkylineDx Announces Prognostic Tool to be Used as Part of Major New Myeloma Clinical Trial
SkylineDx Announces Prognostic Tool to be Used as Part of Major New Myeloma Clinical Trial
ICR to Use SkylineDx’s MMprofiler™ Gene-Based Prognostic Signature in Phase IIb MUK nine High-risk Trial in Multiple Myeloma
Rotterdam, the Netherlands and Laguna Hills, CA, October 12, 2017 – SkylineDx today announced that The Institute of Cancer Research, London (ICR) and University of Leeds will use MMprofiler™ with SKY92, SkylineDx’s prognostic tool to risk-stratify patients with multiple myeloma (MM), in a multi-centric Phase IIb high-risk trial known as MUK nine. The University of Leeds is the sponsor of this trial, which is partly funded by Myeloma UK, and ICR will perform the testing services to include high-risk patients with MM to evaluate an experimental treatment arm alongside standard treatment for these patients.
“Around 20% of myeloma patients are characterized as having high-risk myeloma, yet there is relatively little research looking at high-risk disease and treatment,” said Dr. Simon Ridley, Myeloma UK Director of Research. “This trial is looking to the future – we are trying to gain more insight into which treatment combinations might work best in different groups of high risk patients. We are pleased to work with SkylineDx in our efforts to characterize the potential clinical utility of new therapeutic approaches in high-risk myeloma.”
MMprofiler assesses risk by measuring the activity of 92 genes (the SKY92 gene signature) that are directly or indirectly related to the disease and that determines the level of risk for patients with multiple myeloma by classifying them into a “high” or “standard” risk group. Patients with a “high” risk classification have a poor prognosis as compared to patients with a standard risk profile, regardless of treatment.
“Investigation of new therapeutic approaches in individuals with high-risk multiple myeloma requires accurate and reliable patient identification and risk stratification,” said Dharminder S. Chahal, Chief Executive Officer of SkylineDx. “The use of MMprofiler in the MUK nine trial will facilitate patient selection, and may enhance our understanding of the potential utility of these new treatment modalities in this underserved patient population.”
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.
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. 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.
About Myeloma UK
Myeloma UK is the only organisation in the UK dealing exclusively with myeloma – our ultimate goal is to find a cure. We are dedicated to ensuring that patients get access to the right treatment at the right time, and to improving standards of treatment and care through research, education and awareness raising. Our organisation also provides a range of information and support services to patients, family and friends to help deal with a diagnosis of myeloma.
Myeloma UK receives no government funding and relies almost entirely on voluntary donations and fundraising. For more information, please visit www.myeloma.org.uk.
The Institute of Cancer Research, London, is one of the world's most influential cancer research organisations.
Scientists and clinicians at The Institute of Cancer Research (ICR) are working every day to make a real impact on cancer patients' lives. Through its unique partnership with The Royal Marsden NHS Foundation Trust and 'bench-to-bedside' approach, the ICR is able to create and deliver results in a way that other institutions cannot. Together the two organisations are rated in the top four centres for cancer research and treatment globally.
The ICR has an outstanding record of achievement dating back more than 100 years. It provided the first convincing evidence that DNA damage is the basic cause of cancer, laying the foundation for the now universally accepted idea that cancer is a genetic disease. Today it is a world leader at identifying cancer-related genes and discovering new targeted drugs for personalised cancer treatment.
A college of the University of London, the ICR is the UK’s top-ranked academic institution for research quality, and provides postgraduate higher education of international distinction. It has charitable status and relies on support from partner organisations, charities and the general public.
The ICR's mission is to make the discoveries that defeat cancer. For more information visit http://www.icr.ac.uk.
# # #
Media Inquiries for SkylineDx
Jeffrey Jones, SkylineDx
 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.
11 Oct 2017
26 Jul 2017
21 Jun 2017
10 Apr 2017
30 Nov 2016
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
11 Oct 2016
04 Oct 2016
31 May 2016
08 Mar 2016
01 Dec 2015
25 Nov 2015
08 Sep 2015
19 Aug 2015
02 Jul 2015
08 Jun 2015
17 Feb 2015
11 Nov 2014
06 Nov 2014
14 Oct 2014
22 May 2014
06 Mar 2014
- 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)
- SkylineDx Presented New Algorithm Demonstrating Ability to Successfully Identify Gene Sets that are Informative of Cancer Treatment Specific Survival
- 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
- SkylineDx and Consortium of Leading European Partners awarded multi-million Euro Horizon2020 grant from European Commission
- SkylineDx to Present New Data Demonstrating MMprofiler™ as Robust Prognostic Tool in Multiple Myeloma at the European Hematology Association 21st Annual Congress (EHA)
- SkylineDx Supports Myeloma Awareness Month to Raise Awareness of a Serious and Difficult to Treat Disease
- SkylineDx to Present New Data Demonstrating Prognostic Value of MMprofiler™ in Multiple Myeloma at American Society of Hematology Annual Meeting
- SkylineDx Receives CE-IVD Mark for MMprofiler™ Its Innovative Gene Signature-Based Test for Multiple Myeloma
- SKY92-ISS Superior to current markers in risk classification for myeloma survival
- SkylineDx appoints Leonard Kruimer as CFO Peter Schineller as CCO
- More Accurate Prediction on Prognosis in Multiple Myeloma (bone marrow cancer)
- SkylineDx Presents an Abstract on Risk Identification for Multiple Myeloma Patients at the 20th Congress of the EHA
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;