Datar Cancer Genetics has received US Food and Drug Administration clearance for CellDx-Tissue, a tissue-based comprehensive genomic profiling assay designed for use in solid tumours.

• The assay is a qualitative in vitro diagnostic test using targeted Next-Generation Sequencing of DNA and RNA from formalin-fixed paraffin-embedded tumour tissue.
• It analyses 517 cancer-associated genes, including variants such as somatic single nucleotide variants, small insertions and deletions, ERBB2 gene amplification, and gene fusions involving ALK, RET and ROS1.
• The test is performed as a single-site assay at the company’s CAP- and CLIA-accredited laboratory facility.

This summary is based on a press release issued by Datar Cancer Genetics and distributed via PR Newswire.

Image for illustrative purposes only. Source: Canva.

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