Target Selector EGFR Mutation Test Kit CE IVD

EGFR Testing

Target Selector EGFR Mutation Test Kit CE IVD

Biocept’s Target Selector molecular assay kits detect key oncogene mutations through the analysis of both Formalin-Fixed Paraffin-Embedded (FFPE) tissue gained from surgical biopsies as well as circulating tumor DNA (ctDNA) gained from blood-based liquid biopsies.  The EGFR pathway can include mutations that are among the most frequently evaluated biomarkers for lung cancer.

Benefits of Biocept Target Selector Switch-Blocker Technology

  • Enrichment of cancer biomarker mutations (Del19, L858R, T790M) in a high wild-type background
  • Suppression of wild-type DNA amplification
  • Proofreading DNA Polymerase resulting in lower false positives
  • Avoids damaged DNA templates (such as deaminated cytosines)
  • Ultra-high sensitivity and specificity
  • Combination with Sanger sequencing for orthogonal verification of the enriched mutation
  • Detection of Del19, L858R, T790M as well as wild-type are quantitative

ctDNA Performance

  • Sensitivity: 0.05% mutant allele fraction -single copy detection of mutant in up to 14000 copies of wild-type DNA background
  • Specificity: >99%
  • Effective range of DNA input: 10pg-50ng DNA

FFPE DNA Performance

  • Eliminates need for macrodissection of FFPE tissue by enriching mutations and blocking wild-type DNA amplification
  • Sensitivity thresholds have been established to account for artifacts introduced by formaldehyde fixation
  • Mutant allele frequencies below these cut-offs are considered negative for the mutation
    • Del19 cutoff: 0.17%
    • L858R cutoff: 0.17%
    • T790M cutoff: 2.87%
  • Specificity: >98.4%
  • Effective range of DNA input: 10pg-50ng DNA

These thresholds are provided as a guidance, but every laboratory should establish their own thresholds based on their criteria.

General Specifications

  • Stability: 1 year
  • Storage: 20° C

How the Target Selector EGFR Mutation Test Kit CE IVD Works

CEE-Sure BCT

If you are developing your own assay, learn more about the benefits of our CEE-Sure™ Blood Collection Tube (BCT) for ctDNA and CTCs.

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Target Selector Kits are for research use only. Not for use in diagnostic procedures.