Datar Cancer Genetics Receives FDA Clearance for CellDx Tissue Genomic Test

Datar Cancer Genetics has received clearance from the U.S. Food and Drug Administration for its CellDx Tissue assay, announced in a press release. The comprehensive genomic profiling test is designed for use with solid tumor samples and uses targeted next generation sequencing of DNA and RNA to support clinical decision making.

CellDx Tissue analyzes 517 cancer associated genes, identifying somatic single nucleotide variants, small insertions and deletions, ERBB2 gene amplification, and gene fusions involving ALK, RET, and ROS1. The test is performed at the company’s CAP and CLIA accredited laboratory and is intended to provide standardized genomic information for oncologists.

The FDA clearance follows earlier Breakthrough Device Designations granted to Datar Cancer Genetics for its liquid biopsy platforms. The company stated that the clearance strengthens its ability to collaborate with clinical, academic, and biopharmaceutical partners in research and biomarker development programs.