The tissue-based assay uses DNA and RNA to analyze 517 cancer-associated genes to guide clinical management.
Datar Cancer Genetics announced that its tissue-based genomic profiling assay for solid tumors, CellDx-Tissue, has received clearance from the US Food and Drug Administration (FDA).
The assay is a qualitative in vitro diagnostic test that uses targeted next-generation sequencing of DNA and RNA isolated from formalin-fixed paraffin-embedded tumor tissue. It is intended for use in patients diagnosed with solid tumors to provide information on somatic single nucleotide variants, small insertions and deletions, ERBB2 gene amplification, and gene fusions involving ALK, RET, and ROS1.
The test analyzes 517 cancer-associated genes and is performed at the company’s College of American Pathologists- and Clinical Laboratory Improvement Amendments-accredited laboratory.
“This US FDA clearance for CellDx-Tissue adds gold-standard regulatory endorsement to an important solution offered by Datar Cancer Genetics. CellDx-Tissue bridges the gap between genomic complexity and clinical decision-making, offering patients wider options in an era of rapidly evolving therapies,” says Dr Vineet Datta, senior director of global strategy and business development, in a release.
According to the company, genomic profiling has become a central component of clinical management for solid tumors. The process supports clinicians in characterizing genomic alterations across a broad spectrum of cancer types.
“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,” says Dr Darshana Patil, senior director of group medical affairs, in a release.
The clearance allows the company to engage with clinical, academic, and biopharmaceutical partners on a common regulatory footing for clinical management support, translational research, and biomarker development programs.
“This clearance reflects the consistency, rigor, and clinical orientation our scientific and quality teams have brought to the development of CellDx-Tissue platform,” says Dr Dadasaheb Akolkar, director of research and innovation, in a release.
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