Geneseeq Genetic mutation test kit SHIELDING™ ULTRA

Product catalog summary

Overview: GeneseeqMRD (Geneseeq Shielding™ Ultra) is a CE-marked in vitro diagnostic solution designed for the ultrasensitive surveillance of solid tumors. It detects genetic alterations in 2365 cancer-related genes using circulating tumor DNA (ctDNA) to aid clinical decision-making.

Key Features:

Multi-sample and multi-timepoint monitoring during the perioperative period to assess recurrence and metastasis risks.
Utilizes a pre-defined panel of 2365 clonal genes for MRD tracking, overcoming tumor heterogeneity.
Validated procedures ensure test quality and a turnaround time of 5-7 days.
Ultra-sensitive technology with a limit of detection (LOD) of 0.01%.
Enhanced accuracy through paired tumor/normal tissue sequencing and multiple databases to filter out sequencing noise and CHIP-related mutations.

Sample Requirements:

Tumor Tissues: FFPE slides or extracted gDNA.
Liquid Biopsies: Peripheral blood or extracted ctDNA.
Adaptable to other body fluids like pleural effusion and cerebrospinal fluid.

Testing Strategy:

Baseline tumor assessment using the Geneseeq Plus panel.
ctDNA profiling of mutational hotspots before surgery and at three post-surgery time points.
Normal control profiling at baseline.

Regulatory and Validation:

Developed as a Laboratory Developed Test (LDT) and validated by Geneseeq Technology Inc.
Accredited under CAP, CLIA, and ISO15189:2012.
IVD version cleared by the European Commission (CE-IVD).

Additional Services:

IVD/RUO reagent kits for the entire NGS workflow.
Automated bioinformatic analysis and reporting with GENESIS software.
Customer service including lab space design, staff training, and technical support.

Catalog excerpts

Geneseeq Genetic mutation test kit SHIELDING™ ULTRA-1

*Please see sample requirement information sheet for sample collection, storage, and shipment details. *Test adapted to other body fluids, such as pleural effusion, cerebrospinal fluid, aqueous humor, and urine (Please consult for sample collection requirements). Copyright © 2025. GENESEEQ Technology Inc. All rights reserved.

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Geneseeq Genetic mutation test kit SHIELDING™ ULTRA-2

MINIMAL RESIDUAL DISEASE SURVEILLANCE Perioperative Testing Strategy Adjuvant Treatment NeoAdjuvant Treatment Adjuvant Treatment Post-Adjuvant Treatment Dynamic Monitor Tumor Recurrence & Metastasis The MRD baseline tumor assessment utilizes the Geneseeq Plus panel ctDNA proﬁling of mutational hotspots in 2365 cancer-related genes before surgery and at three time points post-surgery Normal control (white blood cells) proﬁling at baseline Turnaround Time Report expected in 5-7days from sample receipt. ‡ Variant Types Tumor Mutational Burden (TMB) IVD/RUO Reagent Kits Kits contain reagents required...

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