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NGeneBio Receives CE-IVD Mark for NGS-Based Cancer Panel

NEW YORK – South Korean diagnostics company NGeneBio said on Wednesday that it has received CE-IVD marking for its next-generation sequencing-based comprehensive genomic profiling panel for cancer, OncoaccuPanel.

The assay provides optimized targeted therapy information and can detect microsatellite instability and tumor mutation burden, and more than 300 genes that are related to 35 types of cancers such as lung, colon, gastric, and breast cancer. The accompanying software analyzes companion diagnostic biomarkers such as EGFR, BRAF, KRAS, HER2, and ROS1 genes, NGeneBio said.

The test is the second comprehensive genomic profiling test to receive European approval in recent months, following Illumina's TruSight Oncology Comprehensive, which received it in March.

NGeneBio went public in its home country in 2021, raising $32 million. The firm also has CE-IVD marking for its BRCAaccuTest and human leukocyte antigen (HLA) typing test.

In a statement, the firm added that it is in discussions with a CLIA laboratory to bring the test to the US.