Datar Cancer Genetics received FDA clearance for CellDx-Tissue, a comprehensive genomic profiling assay for solid tumors. The dual-analyte test profiles targeted DNA and RNA alterations using a targeted next-generation sequencing format covering 517 genes. According to the company, the DNA component qualitatively assesses single nucleotide variants, small insertions/deletions and ERBB2 amplification, while the RNA component supports fusion calls for ALK, RET and ROS1. The assay is intended for use with formalin-fixed, paraffin-embedded tissue samples. Datar said the clearance broadens clinical decision support as oncology therapies evolve, and that the test will be performed globally in CAP- and CLIA-accredited laboratories, including its U.S. operations outside Raleigh, North Carolina.