GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)
Overview
The GENESEEQPRIME® NGS Tumor Profiling Assay (FFPE) by Geneseeq Technology is an in vitro diagnostic (IVD) test kit designed for comprehensive tumor profiling using next-generation sequencing (NGS). It is intended for use with DNA isolated from formalin-fixed paraffin-embedded (FFPE) tumor tissue from patients previously diagnosed with solid malignant neoplasms.
This assay interrogates 425 cancer-related genes, providing critical information on various genomic alterations. It detects single-nucleotide variants (SNVs), insertions/deletions (indels), and selected gene amplifications and translocations. Additionally, the test reports microsatellite instability (MSI) and tumor mutation burden (TMB).
Delivered as a ready-to-use kit, GENESEEQPRIME® enables decentralized implementation in oncology laboratories, promoting local adoption while ensuring globally harmonized standards. The assay is paired with GENESIS by GENESEEQ®, the company’s proprietary bioinformatics pipeline and reporting system, which has been validated across multiple CLIA/CAP-accredited laboratories. This integrated solution provides laboratories with a streamlined workflow and a consistent framework for data analysis and reporting.
Analytical and clinical validation studies conducted across multiple U.S. clinical laboratories have demonstrated high sensitivity, specificity, and reproducibility across various variant types, supporting its intended use in clinical oncology.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- 425 cancer-related gene panel for comprehensive profiling
- Detects single-nucleotide variants (SNVs) and insertions/deletions (indels)
- Identifies selected gene amplifications and translocations
- Reports Microsatellite Instability (MSI) and Tumor Mutation Burden (TMB)
- Utilizes Next-Generation Sequencing (NGS) technology
- Analyzes DNA from formalin-fixed paraffin-embedded (FFPE) tumor tissue
- Provided as a ready-to-use IVD kit for decentralized laboratory implementation
- Paired with GENESIS by GENESEEQu00ae bioinformatics pipeline and reporting system
- Demonstrated high sensitivity, specificity, and reproducibility
- Supports multi-regional clinical trials and biomarker-driven drug development
Use Cases
- Detection of tumor gene alterations in solid malignant neoplasms
- Guiding personalized cancer treatment decisions, including targeted therapy and immunotherapy
- Supporting biomarker-driven drug development
- Facilitating multi-regional clinical trials with standardized data
- Enabling future companion diagnostic (CDx) strategies
- Decentralized, standardized oncology testing in local laboratories
What Physicians Need to Know
For solid tumor patients, consider GENESEEQPRIME for comprehensive genomic profiling, especially when seeking actionable insights for targeted therapies, immunotherapies, or understanding chemotherapy response and resistance. Its broad panel (425 genes) and assessment of key biomarkers like TMB and MSI can inform personalized treatment strategies. The FDA, CE-IVD, and NMPA clearances provide regulatory assurance, and the reported 5-business-day turnaround time can facilitate timely clinical decisions.
Laboratories considering GENESEEQPRIME should note its specific requirement for the Illumina NextSeq 550Dx Sequencer. The assay integrates with Geneseeq's proprietary GENESIS bioinformatics pipeline for analysis and reporting. As an IVD kit designed for decentralized use, successful integration will depend on existing lab infrastructure, personnel training, and adherence to Geneseeq's protocols for sample preparation and workflow management. Geneseeq's 'Local Testing Solutions' may offer comprehensive support for in-house implementation.
Details
| Category | Oncology AI, Pathology AI |
| Pricing | Contact for pricing — Not publicly available |
| Deployment | Lab-based IVD kit with accompanying bioinformatics software (GENESIS by GENESEEQ®). |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated The GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) received 510(k) clearance (K250003) from the U.S. FDA on August 29, 2025. It is an in vitro diagnostic (IVD) test kit for detecting tumor gene alterations in 425 cancer-related genes from FFPE tumor tissue in patients with solid malignant neoplasms. |
| Integrations | |
| EHR | Not specified |
| Specialties | Oncology, Pathology |
What the Web Says
The GENESEEQPRIME NGS Tumor Profiling Assay (FFPE) is an in vitro diagnostic (IVD) test kit that utilizes next-generation sequencing (NGS) to detect tumor gene alterations in patients with solid malignant neoplasms. The assay analyzes 425 cancer-related genes, identifying various genomic alterations including single nucleotide variants (SNVs), insertions/deletions (indels), gene amplifications, and translocations, while also reporting microsatellite instability (MSI) and tumor mutation burden (TMB). It has received FDA 510(k) clearance, CE-IVD marking, and NMPA approval, enabling its use in oncology laboratories globally.
Overall: PositiveStrengths
- Comprehensive 425-gene panel for tumor profiling, including SNVs, indels, amplifications, translocations, MSI, and TMB.
- FDA 510(k) clearance, CE-IVD marking, and NMPA approval ensure global accessibility and standardized testing.
- Enables decentralized implementation in oncology laboratories, supporting local adoption of precision medicine.
- Paired with GENESIS by GENESEEQ, a proprietary bioinformatics pipeline and reporting system, for streamlined workflow and consistent data analysis.
- High sensitivity, specificity, and reproducibility demonstrated in analytical and clinical validation studies.
- Supports multi-regional clinical trials, biomarker-driven drug development, and companion diagnostic (CDx) strategies.
Limitations
- Information provided by the assay is not intended to be prescriptive or conclusive for the labeled use of any specific therapeutic product.
- FFPE samples can present challenges for NGS due to DNA degradation and potential for artifactual mutations.
- Requires sufficient tumor tissue, and obtaining adequate samples can be a challenge.
- NGS testing, in general, can be expensive, and reimbursement varies.
- Turnaround time for NGS results, while improving, can still be a factor in rapid treatment decisions.
- Some actionable findings from NGS may be linked to experimental options rather than reimbursed therapies.
Based on reviews from: PR Newswire, Precision Oncology News, accessdata.fda.gov, Geneseeq Technology Inc., FDA, Labcorp Oncology, PMC, Reddit, OncLive, BioChain Institute Inc.
Last updated: 2026-07-20
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