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SkylineDx Lands CE-IVD Mark for MMProfiler

NEW YORK (GenomeWeb) – 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 fluorescent in 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.

The firm is based in Rotterdam, Netherlands and has US operations in Laguna Hills, California.