Datar Cancer Genetics receives landmark US FDA clearance for CellDx-Tissue assay

Nashik-based Datar Cancer Genetics (DCG), a global precision oncology company, has announced that its tissue-based comprehensive genomic profiling (CGP) assay for all solid tumours, Cell^Dx-Tissue, has been cleared by the US Food and Drug Administration (US FDA).

Cell^Dx-Tissue is a qualitative in vitro diagnostic (IVD) test that uses targeted Next-Generation Sequencing (NGS) of DNA and RNA isolated from formalin-fixed paraffin-embedded (FFPE) tumour tissue of patients diagnosed with solid tumors.

The assay analyses 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. Cell^Dx-Tissue is a single-site assay performed at Datar Cancer Genetics' CAP- and CLIA-accredited laboratory.

Comprehensive genomic profiling has become a central component of clinical management of solid tumours, supporting clinicians in characterising tumor genomic alterations across a broad spectrum of cancer types.