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  5. Biocept - Model EGFR -CE IVD - Target ...

Biocept - Model EGFR -CE IVD - Target Selector Mutation Test Kit

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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.

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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