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Sophia Genetics Gains CE-IVD Mark for Leukemia Assay

CHICAGO (GenomeWeb) – Sophia Genetics said that it has received a CE-IVD mark for a molecular diagnostics test designed to improve detection of leukemia and other hematological diseases. The Swiss company called this the "world’s first capture-based myeloid clinical solution" to receive this designation from European regulators.

The test is a sequencing-based assay combined with data analytics to detect mutations that cause myeloid and lymphoid leukemia.

According to Lausanne, Switzerland-based Sophia, its technology helps improve genome reads and coverage uniformity, even in areas heavy in Gs and Cs. This, Sophia said, overcomes analytics limitations associated with biomarkers such as CEBPA, FLT3, and CALR.

Sophia Genetics said that its new myeloid test will support both biomarker-driven drug discovery and the personalization of cancer care.

Last week, the company announced that its Sophia AI machine learning platform now supports radiomics analysis. Sophia raised $30 million in a Series D round of venture capital last September.