The FDA cleared Datar Cancer Genetics’ CellDx-Tissue assay for comprehensive genomic profiling of solid tumors. The dual-analyte test uses targeted next-generation sequencing to assess DNA variants and ERBB2 amplification, and RNA testing to identify ALK, RET, and ROS1 fusions. The assay profiles 517 genes linked to cancer, and it is designed for use with formalin-fixed, paraffin-embedded tissue samples. Datar said the test can be performed globally through its CAP- and CLIA-accredited laboratories, including in the U.S. For oncology, the clearance expands options for molecular decision-making as more therapies depend on actionable biomarkers beyond single-gene companion tests. The move also reflects continued growth in validated, tissue-based CGP offerings that integrate DNA and RNA to reduce the number of separate assays clinicians need to order.