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Geneseeq Essencare_Lung cancer CDx

Geneseeq Essencare_Lung cancer CDx

Geneseeq Essencare_Lung cancer CDx

Product catalog summary
Overview
The Essencare™ Lung Cancer CDx Panel is a genomic profiling tool designed for advanced lung cancer patients. It utilizes hybrid capture-based next-generation sequencing to analyze key driver genes and clinically relevant genes, aiding in therapy selection and understanding disease mechanisms.
Key Features
  • Includes 14 core lung cancer genes such as EGFR, ALK, ROS1, BRAF, KRAS, and others.
  • Four companion diagnostics (CDx) indications.
  • Validated for SNV, Indel, CNV, and Fusion with high detection sensitivity.
Performance Specifications
  • Biomarker prevalence in NSCLC with NMPA-approved therapies includes EGFR exon 19 deletion, EGFR L858R, ALK, and ROS1 rearrangements.
  • Gene variant detection limits range from 1% to 2.5% for various mutations.
  • Comparative studies show over 98% concordance with gold-standard methods and 100% agreement with approved diagnostic kits.
Turnaround Time
Reports are expected within 5-7 days from sample receipt.
Validation and Accreditation
  • Developed as a Laboratory Developed Test (LTD) and validated by Geneseeq Technology Inc.
  • Accredited under CAP, CLIA, and ISO15189:2012.
  • Cleared by the China National Medical Products Administration.
IVD/RUO Reagent Kits
  • Includes reagents for the entire NGS workflow, from nucleic acid extraction to automated bioinformatic analysis.
  • Supported by GENESIS software for analysis and reporting.
Sample Requirements
  • Tumor tissues: 5-15 FFPE slides or at least 100 ng of extracted gDNA from fresh tissue or FFPE.
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Catalog excerpts

Geneseeq Essencare_Lung cancer CDx-1

COMPREHENSIVE GENOMIC PROFILING EssencareTMLung Cancer CDxNMPA-approvedAbout Essencare™^ The Essencare™ Lung Cancer CDx Panel is a focused genomic profiling solution for patients with advanced lung cancer using hybrid capture-based next-generation sequencing.The panel includes six key driver genes to support therapy selection with approved targeted treatments and eight clinically relevant genes to understand disease mechanisms and aid clinical decision-making for emerging therapeutics. fKey Features v/ Panel includes 14 core lung cancer genes: EGFR, ALK, ROS1, BRAF, KRAS, HER2, RET, MET, NRAS, PIK3CA, AKT1, PTEN, NF1, MEK1 v' Four CDx indicationsv' Fully validated for SNV, Indel, CNV, Fusion with high detection sensitivityCompanion diagnostics (CDx) indications Biomarker Prevalence in NSCLC NMPA-Approved Therapy EGFR exon 19 deletion & EGFR L858R 45%-55% Iressa® (gefitinib) Conmana® (icotinib) EGFR T790M >50% Tagrisso® (osimertinib) ALK rearrangements 5%-10% Xalkori® (crizotinib) Validated through large-scale clinical studies 'Z Comparative studies with gold-standard methods, including fluorescent PCR, FISH, and Sanger sequencing, showed an overall concordance rate above 98%. ^ Consistency analysis with approved EGFR, ALK, and ROS1 companion diagnostic kits demonstrated 100% overall agreement. Retrospective clinical studies: patients with EGFR sensitizing mutations or ALK/ROS1 fusions detected by Essencare achieved therapeutic outcomes consistent with those observed in prior clinical trials. Copyright © 2025. GENESEEQ Technology Inc. All rights reserved.

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Geneseeq Essencare_Lung cancer CDx-2

COMPREHENSIVE GENOMIC PROFILING Sample Requirement Tumor Tissues: FFPE Slides: 5-15 slides (Or unstained slides of biopsy or surgical specimen) Extracted gDNA from fresh tissue or FFPE: at least 100 ng Turnaround Time Report expected in 5-7 days form sample receipt.‡ Variant Types Single Nucleotide Variants (SNVs) Small Insertion and Deletion Variants (indels) Gene Translocations IVD/RUO Reagent Kits Kits contain reagents required for entire NGS workflow Built-in analysis solutions Customer service Nucleic acid extraction Library preparation Targeted enrichment Validated workstation adpated for...

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