FDA-Cleared Genomic Profiling Assay Guides Treatment Selection in Solid Tumors

S. Food and Drug Administration (FDA) clearance. The assay is intended to support personalized clinical management decisions in accordance with professional guidelines and is performed as a single-site test at a CAP- and CLIA-accredited laboratory.

The technology employs targeted next‑generation sequencing of DNA and RNA isolated from formalin‑fixed paraffin‑embedded (FFPE) tumor tissue. It analyzes 517 cancer‑associated genes and reports somatic single nucleotide variants, small insertions and deletions, ERBB2 gene amplification, and gene fusions involving ALK, RET, and ROS1. Fusion calls are based on RNA‑level evidence within a dual‑analyte DNA/RNA workflow.

The FDA clearance process spans analytical, clinical, and information technology domains. The clearance recognizes the assay’s dual‑analyte design and complements earlier FDA Breakthrough Device Designations received for the company’s liquid biopsy platforms. The platform is intended for use by oncologists globally to aid personalized clinical decision‑making.

“This US FDA clearance for CellDx-Tissue adds gold-standard regulatory endorsement to an important solution offered by DCG. CellDx-Tissue bridges the gap between genomic complexity and clinical decision-making, offering patients wider options in an era of rapidly evolving therapies. We're proud to bring this technology to oncologists worldwide,” said Dr. Vineet Datta, Senior Director, Global Strategy and Business Development.

“US FDA clearance of our tissue-based genomic panel is a substantive validation of our science and quality systems. It enables us to support oncologists with robust, standardized genomic information to guide complex treatment decisions, and reinforces our commitment to combining advanced genomics, rigorous science, and real-world clinical relevance in service of cancer patients,” said Dr. Darshana Patil, Senior Director, Group Medical Affairs.

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