Datar Cancer Genetics FDA Clears CellDx‑Tissue

Datar Cancer Genetics announced US FDA clearance for its CellDx‑Tissue assay, a dual‑DNA/RNA genomic profiling test for solid tumors.
The assay evaluates 517 cancer‑associated genes, detecting SNVs, indels, ERBB2 amplification and ALK, RET, ROS1 fusions via RNA evidence.
CellDx‑Tissue is performed at DCG’s CAP‑ and CLIA‑accredited lab, reinforcing its AI‑driven precision oncology platform and prior FDA Breakthrough designations.
Senior directors Vineet Datta, Darshana Patil and Director Dadasaheb Akolkar highlighted the regulatory endorsement’s impact on global clinical decision‑making.