SkylineDx, a biotech company specializes in the development and marketing of innovative gene signature-based tests to assist healthcare professionals, has received CE-IVD registration from the European Competent Authority (Ministry of Health) for the MMprofiler, the company's prognostic test to determine the level of risk of a patient with multiple myeloma (MM). This market authorization is an important step in raising the standards for gene expression profiling and bringing the MMprofiler to a wider market.
"Receiving this CE-IVD mark is our first, and most significant, commercialization milestone for MMprofiler," said Dharminder S. Chahal, chief executive officer of SkylineDx. "We are one step closer to fulfilling our commitment to advancing the use of innovative gene signature-based tests to help physicians make better informed personalized treatment decisions for patients with multiple myeloma worldwide."
The CE-IVD certification will enable European physicians to access this important advancement and now offer it to their multiple myeloma patients. MMprofiler provides physicians with the ability to utilize the well-validated SKY92 "high-risk signature" to more accurately measure the prognosis of a patient 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. The performance of the SKY92 gene signature to risk stratify these patients exceeds that of current standard clinical parameters such as serum albumen levels, as well as FISH, utilized in myeloma.
The CE-mark (CE-IVD) indicates that an IVD device complies with the European In Vitro Diagnostics Directive (98/79/EC), and that the device may be legally commercialized and distributed in the EU.
Multiple myeloma is a type of blood cancer that arises from plasma cells, a type of white blood cell, which is made in the bone marrow. Most medical problems related to multiple myeloma are caused by the build-up of abnormal plasma cells in the bone marrow and the presence of paraprotein in the blood or in the urine. While multiple myeloma does not exist as a tumor, the malignant plasma cells may cause the formation of tumors throughout the body, damage to the kidneys and will impair immune system function.
The MMprofiler is a 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 well-validated SKY92 gene signature. These high-risk multiple myeloma patients have a high unmet medical need for improved therapies. In the USA the MMprofiler is available for research use only and currently not permitted to be used for clinical diagnostic use.