On May 14, 2026, Datar Cancer Genetics announced that its tissue-based comprehensive genomic profiling assay, CellDx-Tissue, received US FDA clearance for use in solid tumors.
CellDx-Tissue is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing of DNA and RNA from formalin-fixed paraffin-embedded (FFPE) tumor tissue.
The assay analyzes 517 cancer-associated genes and is intended to identify somatic SNVs, small InDels, ERBB2 amplification, and gene fusions involving ALK, RET, and ROS1.
The clearance was described as a major regulatory milestone that strengthens Datar Cancer Genetics' position in precision oncology and supports personalized clinical management decisions.
The company noted that the assay is performed at its CAP- and CLIA-accredited laboratory and complements earlier US FDA Breakthrough Device Designations for its liquid biopsy platforms.