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

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

Business

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

2026-05-14 23:58 Last Updated At:05-15 00:15

Clearance Recognises CellDx-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, CellDx-Tissue, has been cleared by the US Food and Drug Administration (US FDA).

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 CellDx-Tissue

CellDx-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. CellDx-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 CellDx-Tissue adds gold-standard regulatory endorsement to an important solution offered by DCG. CellDx-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 CellDx-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

 

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

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

SHANGHAI, May 16, 2026 /PRNewswire/ -- INS LAND, the urban entertainment complex recently ranked No.12 in DJ Mag's 2026 Top 100 Clubs worldwide and No.3 in Asia, announced the opening of three new venues: Soul House, an immersive club; Radi, a fully reimagined and expanded reopening; and Jump, a new high-energy club featuring a spring-loaded dance floor designed to keep guests literally off the ground.

"Soul House, Radi, and Jump are our answer to 2026," said Leo Liu, Cofounder & Head of Brand and Growth at INS LAND. "Each one is a new chapter in INS LAND's vision of bringing the gaming world to life — with a single ticket, guests don't just visit a venue; they enter a world where experiences are reborn every 45 days."

The openings mark a strategic evolution ahead of INS LAND's third anniversary on June 16, 2026, shifting from a "club cluster" identity into a multi-format urban playground. The brand now spans 20 fully owned and operated venues under one ticketed ecosystem.

Soul House is INS LAND's most ambitious immersive concept to date. It features multiple themed rooms, each with its own narrative universe. Guests move through distinct worlds with beverage items, scenography, and storytelling elements, blending immersive theatre and spatial design into a layered experience.

Radi returns after a complete transformation, with an expanded footprint, upgraded sound and lighting systems, and a refreshed design direction positioning it as a signature, design-forward destination within the INS LAND portfolio.

Jump introduces a new experiential format centered on movement. Built around a spring-loaded dance floor, it features high-energy programming across electronic and bounce genres, designed to create a physically kinetic nightlife experience.

About INS LAND

INS LAND is a 20-venue urban entertainment complex in central Shanghai, combining nightlife, immersive experiences, dining, and music under one unified brand. With a single-ticket model granting access across venues, it welcomed over 4 million visitors in 2025 and ranks No.12 globally in DJ Mag's Top 100 Clubs. The platform refreshes its core themes every 45 days and its mobile app supports over 1 million active users across online and offline experiences. INS LAND has collaborated with brands including Mercedes-Benz, Nike, Douyin, Doritos, and Publicis Groupe, and is preparing international expansion with INS LAND Bangkok planned for 2027.

More information: INS LAND Official Site

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Shanghai's INS LAND Unveils Three New Immersive Venues -- Soul House, Radi, and Jump

Shanghai's INS LAND Unveils Three New Immersive Venues -- Soul House, Radi, and Jump

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