FDA cleared Datar Cancer Genetics’ CellDx-Tissue assay for comprehensive genomic profiling of solid tumors, enabling DNA and RNA testing on formalin-fixed, paraffin-embedded tissue. The dual-analyte panel uses targeted next-generation sequencing to assess single nucleotide variants, small insertions/deletions and ERBB2 amplification alongside fusion calling for ALK, RET and ROS1. The clearance matters for companion-like clinical decision pathways because it expands access to multiplex tumor genotyping that can be used for treatment selection and trial matching. Datar said the assay runs in its CAP- and CLIA-accredited labs and can be used globally, with US operations included. With clearance, the company can deepen distribution in solid tumor cohorts where clinicians need actionable genomic calls quickly.