Clearance Recognises Cell^Dx-Tissue's Dual-Analyte DNA and RNA Workflow Across 517 Cancer-Associated Genes, with ALK, RET and ROS1 Fusion Calls on RNA-Level Evidence

Datar Cancer Genetics (DCG), a global precision oncology company,  announced that its tissue-based comprehensive genomic profiling (CGP) assay for all solid tumors, Cell^Dx-Tissue, has been cleared by the US Food and Drug Administration (US FDA).

Cell^Dx-Tissue

Cell^Dx-Tissue is a qualitative in vitro diagnostic (IVD) test that uses targeted Next-Generation Sequencing (NGS) of DNA and RNA isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue of patients diagnosed with solid tumors. The assay analyses 517 cancer-associated genes and is intended to provide information on somatic single nucleotide variants (SNVs), small insertions and deletions (InDels), ERBB2 gene amplification, and gene fusions involving ALK, RET and ROS1. Cell^Dx-Tissue is a single-site assay performed at Datar Cancer Genetics' CAP- and CLIA-accredited laboratory.

Significance

Comprehensive genomic profiling has become a central component of clinical management of solid tumors, supporting clinicians in characterising tumor genomic alterations across a broad spectrum of cancer types. The US FDA clearance process is intensive and rigorous, spanning analytical, clinical, and information technology domains.  

The clearance consolidates DCG's position to engage with international clinical, academic and biopharmaceutical partners on a common regulatory footing for clinical management support, translational research, and biomarker development programs.

Dr. Vineet Datta, Senior Director – Global Strategy and Business Development, said: "This US FDA clearance for Cell^Dx-Tissue adds gold-standard regulatory endorsement to an important solution offered by DCG. Cell^Dx-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."

"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, standardised 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.

Dr. Dadasaheb Akolkar, Director – Research & Innovation, added, "This clearance reflects the consistency, rigor and clinical orientation our scientific and quality teams have brought to the development of Cell^Dx-Tissue platform. We look forward to extending our transformational precision oncology solutions to cancer patients across global markets."