# Datar Cancer Genetics Receives Landmark US FDA Clearance for CellDx-Tissue, a Comprehensive Genomic Profiling Assay for Solid Tumors Using DNA + RNA

- Link: https://www.thailand-business-news.com/pr-news/datar-cancer-genetics-receives-landmark-us-fda-clearance-for-celldx-tissue-a-comprehensive-genomic-profiling-assay-for-solid-tumors-using-dna-rna
- Published: 2026-05-14T22:58:00+07:00
- Author: PR Newswire

_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_

NASHIK, India, May 14, 2026 /PRNewswire/ — Datar Cancer Genetics (DCG), a global
precision oncology company, today 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).

 [⌊CellDx-Tissue- Comprehensive Genomic Profiling Assay⌉](https://mma.prnasia.com/media2/2980273/Datar_Cancer_Genetics_US_FDA.jpg?p=medium600)

CellDx-Tissue- Comprehensive Genomic Profiling Assay

The clearance strengthens DCG’s position in delivering a breakthrough platform intended
for use by oncologists globally to make personalised clinical management decisions
in accordance with professional guidelines and complements the company’s earlier
US FDA Breakthrough Device Designations for its liquid biopsy platforms.

**About 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."_

**About Datar Cancer Genetics**

Datar Cancer Genetics is a global, AI-driven precision oncology company focused 
on developing and delivering advanced cancer diagnostics, including non-invasive
liquid biopsy and tissue-based multi-omic solutions, for early detection, treatment
selection and cancer monitoring. With UKAS-, CAP- and CLIA-accredited laboratories
and a presence across the United Kingdom, the European Union, the United States,
the Gulf Cooperation Council and Asia, DCG partners with clinicians and cancer centers
worldwide to enable personalised cancer care for patients with solid organ cancers.

Web: [https://datarpgx.com/celldx-tissue](https://datarpgx.com/celldx-tissue)

 

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