Products

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)
Geneseeq Technology
Oncology AI
The GENESEEQPRIME® NGS Tumor Profiling Assay (FFPE) is an FDA-cleared in vitro diagnostic (IVD) test kit by Geneseeq Technology. It uses next-generation sequencing to detect tumor gene alterations across 425 cancer-related genes in FFPE tissue, including SNVs, indels, amplifications, translocations, MSI, and TMB, to guide precision oncology.

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About Geneseeq Technology

Geneseeq Technology Inc. is a research-driven global leader in precision oncology, leveraging cutting-edge next-generation sequencing (NGS) technologies to advance cancer detection, diagnosis, and treatment. The company offers comprehensive genomic profiling services, including pan-cancer panels analyzing over 400 genes and cancer-type-specific panels, to provide physicians with actionable insights for guiding optimal treatment strategies, such as targeted therapy and immunotherapy. Their portfolio also encompasses minimal residual disease (MRD) monitoring and multi-cancer early detection (MCED) solutions, with notable products like CanScan® having received FDA Breakthrough Device Designation and GeneseeqPrime® gaining FDA 510(k) clearance, CE-IVD marking, and NMPA approval across major jurisdictions.

Geneseeq integrates advanced AI and machine learning algorithms into its technology platforms for enhanced data analysis and improved diagnostic capabilities. Examples include their TRANQUIL® system for high-resolution gene copy analysis and Calibrate™ for predicting disease relapse through dynamic monitoring of circulating tumor DNA (ctDNA). They have developed proprietary technologies such as ATG-Seq™ for ultra-deep sequencing with three levels of error correction, significantly improving ctDNA detection sensitivity and specificity by addressing challenges like low ctDNA proportion and background noise. Through extensive collaborations with pharmaceutical and academic partners, and by utilizing a large liquid biopsy multi-omics database, Geneseeq is actively involved in biomarker discovery and translational research, aiming to continuously innovate and improve patient outcomes through personalized cancer care.

Focus Areas

Precision Oncology Next-Generation Sequencing (NGS) Genomic Profiling Cancer Diagnosis Prognosis Treatment Guidance Drug Development Liquid Biopsy Minimal Residual Disease (MRD) Monitoring Multi-Cancer Early Detection (MCED) AI-driven Whole-Genome Sequencing Bioinformatics Translational Research

Business Intelligence

Key InvestorsCowin Capital, Guoxin Capital, Xingye Innovation Capital Management, Lilly Asia Ventures, SoftBank China Venture Capital, China Reform Holdings Corporation
PartnershipsJiangsu Vcare PharmaTech, Zai Lab, Illumina, AstraZeneca, Integrated DNA Technologies (IDT)
TechnologyNext-Generation Sequencing (NGS) platforms, High-Performance Computing (HPC) data center, Machine Learning algorithms, exclusive genomic databases, proprietary bioinformatics pipeline (GENESIS by GENESEEQ), AI-driven whole-genome sequencing (MERCURY™ Technology, ATG-Seq™ Technology, TRANQUIL®)
FDA Clearances1 cleared products (estimated)

What Physicians Need to Know

Precision Oncology & Genomic Profiling
Geneseeq specializes in advanced Next-Generation Sequencing (NGS)-based precision oncology services, offering comprehensive genomic profiling solutions for all tumor types. This includes pan-cancer panels analyzing over 400 genes and cancer-specific panels for diagnosis, prognosis, treatment guidance, and drug development.
Liquid Biopsy & Early Cancer Detection
A leader in liquid biopsy, Geneseeq utilizes cell-free DNA (cfDNA) for minimal residual disease (MRD) monitoring and multi-cancer early detection (MCED). Their proprietary ATG-Sequ2122 technology employs ultra-deep sequencing with three levels of error correction for high sensitivity and specificity in circulating tumor DNA (ctDNA) detection. They have developed groundbreaking AI-powered blood tests for early detection of cancers like pancreatic cancer, leveraging cfDNA fragmentomics.
AI-Powered Bioinformatics
Geneseeq integrates advanced machine learning algorithms and AI into their bioinformatics pipelines for enhanced data analysis. This includes reducing background noise (BISC), distilling signals for gene copy analysis (TRANQUILu00ae), and developing highly accurate early cancer detection models based on cfDNA fragmentomics.
Research & Development Focus
As a research-driven company, Geneseeq has deep scientific expertise and an active R&D program. They collaborate extensively with biopharma and research partners on over 2000 projects and have published more than 550 translational research papers in peer-reviewed journals, continuously advancing cancer care.
Physician Tip

For physicians, Geneseeq Technology offers actionable genomic insights that can significantly guide personalized treatment strategies, including targeted therapies and immunotherapies, by identifying key oncogenic drivers and resistance mechanisms. The availability of highly sensitive, non-invasive liquid biopsy tests for early detection, MRD monitoring, and tracking treatment response/resistance is particularly valuable, especially in cases where tissue biopsies are challenging or for longitudinal surveillance. The rapid turnaround times and high accuracy of their NGS tests, backed by extensive research and regulatory approvals (e.g., FDA Breakthrough Device Designation for CanScanu00ae, NMPA approval for GeneseeqPrimeu2122), provide reliable data for timely clinical decision-making and potentially improved patient outcomes.

Geneseeq offers both central lab testing services and local testing solutions, which include all-inclusive kits and automated bioinformatics software. This suggests potential for various levels of integration, from sending samples to their CLIA/CAP-certified laboratories to enabling in-house genomic testing capabilities for clinical and research partners. They also engage in collaborations with biopharma and research institutions, indicating opportunities for data sharing and research-focused integrations.

Products by Geneseeq Technology

1 product in the directory

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)
Geneseeq Technology
Oncology AI
The GENESEEQPRIME® NGS Tumor Profiling Assay (FFPE) is an FDA-cleared in vitro diagnostic (IVD) test kit by Geneseeq Technology. It uses next-generation sequencing to detect tumor gene alterations across 425 cancer-related genes in FFPE tissue, including SNVs, indels, amplifications, translocations, MSI, and TMB, to guide precision oncology.

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Press & Coverage

Geneseeq Technology Inc.
Geneseeq Canada Named First Genomic Testing Partner in UHN's SHERLOCK Study
Geneseeq Canada has partnered with University Health Network's SHERLOCK study to provide genomic testing and molecular monitoring services for approximately 1,000 patients in this large-scale cancer genomics and molecular residual disease research initiative.
2026-07
GenomeWeb
Geneseeq Advances 'Fragmentomic' Cell-Free DNA Analysis With Novel Computational Model
Geneseeq Technology has developed Fragmentia-AI, an AI-based method to enhance the generalizability and sensitivity of fragmentomic cell-free DNA analysis across various cancer types and platforms.
2026-06
Geneseeq Technology Inc.
Geneseeq Receives NMPA Approval for PanTRKareu2122 u2013 China's First NGS-Based Pan-Solid Tumor Companion Diagnostic Kit for NTRK Gene Fusions
Geneseeq Technology Inc. announced NMPA marketing authorization for its PanTRKareu2122 NTRK1/NTRK2/NTRK3 Gene Fusion Detection Kit, making it China's first NGS-based pan-solid tumor companion diagnostic for NTRK gene fusions.
2025-11
Geneseeq Technology Inc.
GeneseeqPrimeu00ae Gains FDA 510(k) Clearance
Geneseeq Technology Inc. received FDA 510(k) clearance for its GENESEEQPRIMEu00ae NGS Tumor Profiling Assay, a comprehensive in vitro diagnostic test kit for detecting tumor gene alterations in solid malignant neoplasms.
2025-09
Geneseeq Technology Inc.
Geneseeq's Breakthrough Cancer Detection Blood Test Published in Nature Medicine
Geneseeq announced the publication of results from its large-scale multi-cancer early detection (MCED) study, DECIPHE-Omnia, in Nature Medicine, highlighting the high accuracy of its CanScanu00ae blood test.
2025-05
Geneseeq Technology Inc.
Geneseeq Unveils Groundbreaking Blood Test for Early Detection of Pancreatic Cancer
Geneseeq Technology Inc., in collaboration with clinical institutions, has developed a new blood-based screening test for early detection of pancreatic cancer, published in the Journal of Clinical Oncology.
2025-05
Geneseeq Technology Inc.
FDA Grants Breakthrough Device Designation for Geneseeq's Multi-cancer Early Detection Solution
Geneseeq's multi-cancer early detection solution, CanScanu2122, received Breakthrough Device Designation from the U.S. FDA, recognizing its potential to address unmet medical needs in early cancer diagnosis.
2024-01
Newswire.ca
Geneseeq Gains CE Marks for NGS-based Test Kits for Solid Tumors and Hematological Cancer
Geneseeq Technology Inc. announced that three of its next-generation sequencing (NGS)-based cancer genetic testing kits, GeneseeqPrimeu2122, GeneseeqPrimeu2122 HRD, and Hemasalusu2122 DNA/Hemarnau2122 RNA, have obtained CE Mark approval.
2023-08

Frequently Asked Questions

Geneseeq Technology provides a range of AI-powered precision oncology solutions, including comprehensive genomic profiling with GeneseeqPrimeu2122 for solid tumors, minimal residual disease (MRD) monitoring with Shieldingu2122 ULTRA MRD, and multi-cancer early detection (MCED) with CanScanu00ae. These products leverage AI and machine learning in their bioinformatics pipelines for enhanced accuracy in detecting genomic alterations and predicting cancer relapse.
Geneseeq Technology ensures regulatory compliance through multiple international approvals, including FDA 510(k) clearance for GeneseeqPrimeu2122, CE-IVD marking for several diagnostic kits, and NMPA approval in China. Their laboratories are CLIA/CAP-certified and ISO 15189-accredited, demonstrating adherence to high quality and data security standards for patient information.
Geneseeq offers comprehensive support for healthcare professionals, including a streamlined workflow from sample preparation to report generation, and automated bioinformatics software for local testing solutions. They also provide consultation for interpreting complex genomic data and integrating their advanced NGS-based tests into existing clinical practices.
Geneseeq actively collaborates with biopharma companies, research institutions, and clinicians to accelerate biomarker discovery, optimize clinical trial design, and develop companion diagnostics. Notable partnerships include collaborations with Illumina for developing in-vitro diagnostic kits and co-establishing in-house NGS labs with hospitals globally to expand access to precision oncology.
Geneseeq's AI algorithms are developed and validated through extensive research and large-scale clinical studies, such as the DECIPHER-Omnia Study for CanScanu00ae, demonstrating high accuracy in detecting early-stage cancers and low false-positive rates. Their proprietary technologies like ATG-Sequ2122 and MERCURYu2122 incorporate machine learning and multi-level error correction to ensure high sensitivity and specificity in their genomic analyses.
Geneseeq aims to make advanced genomic testing accessible by offering both central laboratory testing and all-inclusive kits for local, in-house genomic testing, which can help streamline processes and potentially lower costs. Their high-throughput sequencing platforms also contribute to cost-efficiency and rapid turnaround times, facilitating broader adoption of precision cancer care.
Geneseeq Technology, founded in 2012, has demonstrated financial stability by raising over $114 million in funding, including a Series D round. The company's long-term vision is to transform cancer care globally by continuously advancing its cutting-edge genomic profiling technology and AI-powered solutions to improve patient outcomes through earlier detection, accurate diagnosis, and personalized treatment.

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