FDA cleared Datar Cancer Genetics’ CellDx-Tissue assay for comprehensive genomic profiling in solid tumors, enabling dual DNA and RNA analysis from formalin-fixed paraffin-embedded samples. The targeted next-generation sequencing panel covers 517 cancer genes and includes RNA calls for ALK, RET, and ROS1 fusions. The clearance expands diagnostic tool availability for treatment selection as targeted therapies proliferate, and it positions Datar to compete for clinical placement in both U.S. and global laboratory networks. Datar stated the assay runs in CAP- and CLIA-accredited labs and can support broader clinical decision-making aligned with rapidly evolving solid tumor regimens. For the diagnostics market, the FDA action highlights sustained regulator focus on analytically robust panels that connect genomics complexity to clinical actionability.