Datar Cancer Genetics received FDA clearance for its CellDx-Tissue comprehensive genomic profiling assay to profile DNA and RNA from solid tumors. The targeted next-generation sequencing panel assesses variants across 517 genes and also uses RNA to call for key fusion events. According to the company, CellDx-Tissue can be run on formalin-fixed, paraffin-embedded samples across solid tumor types, including DNA variant detection and ERBB2 amplification calls. RNA analysis covers ALK, RET, and ROS1 fusions. The clearance strengthens Datar’s position in the expanding US market for tissue-based comprehensive genomic profiling tests, including those intended to guide therapy selection in an era of increasingly biomarker-driven oncology care.