ROTTERDAM, Netherlands and LAGUNA HILLS, Calif., March 8, 2016 — SkylineDx today announces its support for Myeloma Awareness Month, an effort conducted throughout the month of March by the International Myeloma Foundation (IMF) to increase patient education of multiple myeloma, a bone marrow cancer that arises from malignant plasma cells.
“Myeloma Awareness Month gives the multiple myeloma community increased visibility and a public platform to promote education and awareness of this debilitating disease,” said Dharminder S. Chahal, Chief Executive Officer of SkylineDx. “With an estimated 114,000 diagnoses occurring around the world each year, SkylineDx is committed to improving global access to patient education and prognostic tests, such as the MMprofiler®, that enables physicians to quickly and confidently identify multiple myeloma patients at high risk for poor overall survival and short time to progression.
SkylineDx markets the MMprofiler, the only CE-marked in vitro diagnostic (IVD) test backed by peerreviewed published data designed to risk-stratify newly diagnosed and relapsed patients with multiple myeloma.
The MMprofiler is a prognostic test that determines the level of risk for patients with multiple myeloma by classifying them into a “high” or “standard” risk group. The MMprofiler assesses risk by measuring the activity of 92 genes (the SKY92 gene signature) that are directly or indirectly related to the disease. Patients with a “high” risk classification have a poor prognosis as compared to patients with a standard risk profile, regardless of treatment. The performance of the SKY92 gene signature to risk stratify these patients exceeds that of standard clinical parameters such as serum albumin levels, as well as FISH, and earlier gene expression signatures utilized in myeloma.
“Due to the unique genomic properties of cancer cells, multiple myeloma and subsequent treatments behave differently in each individual patient,” said David Siegel, M.D., PhD, Chief, Myeloma Division, John Theurer Cancer Center, Hackensack University Medical Center and member of SkylineDx’s scientific advisory board. “As a result, it is critically important for physicians to make a careful assessment of genomic properties in newly diagnosed patients in order to choose the most suitable therapy. The use of prognostic tests such as the MMprofiler in early stages of the disease, or when patients relapse, allows physicians to potentially identify the most effective treatment path forward while diminishing the risk for unnecessary therapies and costly procedures that may exacerbate the disease.”
The MMprofiler was launched in November 2015 as a CE-marked in vitro diagnostic (IVD) test kit in Europe. Physicians can now send their multiple myeloma patient samples directly to SkylineDx to be run as a service in their central laboratory located in Rotterdam, the Netherlands. It also enables molecular diagnostic laboratories throughout Europe to use the MMprofiler for analysis at their own facilities. The MMprofiler is currently available for research use only in the U.S.
For more information about Myeloma Awareness Month go to www.Myeloma.org.
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 paraprotein – which has no useful function. It is often through the measurement of paraprotein that MM is diagnosed and monitored. Most medical problems related to MM are caused by the build-up of abnormal plasma cells in the bone marrow and the presence of the paraprotein in the blood or urine. The most common symptoms of MM include bone pain, recurring infection, kidney damage, and fatigue. 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, or www.myeloma.org
About the MMprofiler™
The MMprofiler™ is a CE-IVD marked prognostic test to determine the level of risk of a multiple myeloma patient by classifying such patient into a “high” or “standard” risk group with the use of the novel SKY92 gene signature. In the USA the MMprofiler™ is available for research use only and currently not permitted to be used for clinical diagnostic use. For more information, please visit www.MMprofiler.com.
About SkylineDx
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 diagnostic 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. The MMprofiler™ is the company’s lead product. To learn more, please visit www.skylinedx.com.
