Precision oncology company Datar Cancer Genetics (DCG) announced on Thursday that the US Food and Drug Administration (FDA) has cleared its tissue-based comprehensive genomic profiling (CGP) assay for all solid tumours.
CellDx-Tissue, a qualitative in vitro diagnostic (IVD) test, uses targeted Next-Generation Sequencing (NGS) of DNA and RNA isolated from formalin-fixed paraffin-embedded (FFPE) tumour tissue of patients diagnosed with solid tumours. The assay evaluates 517 cancer-associated genes and is intended to provide information on somatic single nucleotide variants (SNVs), small insertions and deletions (InDels), ERBB2 gene amplification, and gene fusions involving ALK, RET and ROS1.
CellDx-Tissue is a single-site assay performed at Datar Cancer Genetics' CAP- and CLIA-accredited laboratory.
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