Datar Cancer Genetics received FDA clearance for its CellDx-Tissue comprehensive genomic profiling test for solid tumors. The dual-analyte assay combines targeted next-generation sequencing of DNA and RNA from formalin-fixed, paraffin-embedded tissue to support identification of DNA variants and key RNA fusions. The test covers alterations in 517 cancer-associated genes and includes RNA fusion calls for ALK, RET, and ROS1, aiming to help clinicians connect molecular findings to increasingly therapy-driven treatment decisions. Datar said the clearance reinforces its move toward broader uptake in CAP- and CLIA-accredited labs. Diagnostics clearance also signals continued FDA attention on multi-modal sequencing platforms that can widen actionable information without requiring separate workflow systems for DNA and RNA profiling.
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