India’s Datar Cancer Genetics Wins FDA Clearance for Tissue-Based Cancer Test

CellDx-Tissue analyzes 517 genes in FFPE tumor samples and is performed at the company’s CAP- and CLIA-accredited laboratory in Nashik, India.

Datar Cancer Genetics has received FDA clearance for CellDx-Tissue, its comprehensive genomic profiling assay for solid tumors, the India-based company said on May 14.

“This clearance reflects the consistency, rigor and clinical orientation our scientific and quality teams have brought to the development of CellDx-Tissue platform,” Dadasaheb Akolkar, director of research and innovation at DCG, said in a statement. “We look forward to extending our transformational precision oncology solutions to cancer patients across global markets.”

The regulatory action sets the company up to pursue partnerships with clinical, academic, and biopharmaceutical organizations.

CellDx-Tissue is an in vitro diagnostic test that uses targeted next-generation sequencing of DNA and RNA extracted from FFPE tumor tissue. The assay covers 517 cancer-associated genes and is designed to detect single nucleotide variants, small insertions and deletions, ERBB2 gene amplification, and gene fusions involving ALK, RET, and ROS1. The test is performed at DCG’s CAP- and CLIA-accredited laboratory in Nashik, India.

The company has previously gained FDA Breakthrough Device Designation for its liquid biopsy platforms.