SkylineDx, today announced they have 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). SkylineDx is an emerging commercial-stage company focused on the development and commercialization of innovative gene signature-based tests. 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.