Dutch molecular diagnostics firm SkylineDx today announced it has received CE-IVD certification for its MMprofiler.
The test determines prognosis risk for multiple myeloma patients based on the SKY92 gene signature and is used to stratify patients into standard and high-risk groups. The firm said in a statement that the gene signature outperforms current standard risk indicators for myeloma, such as serum albumen levels and fluorescentin situ hybridization.
"Receiving this CE-IVD mark is our first, and most significant, commercialization milestone for MMprofiler," SkylineDx CEO Dharminder Chahal said in a statement.
The MMprofiler is not the first CE-marked test for the Erasmus Medical Center spinout. SkylineDx already offers a CE-marked acute myeloid leukemia test called AMLprofiler.