Biocept - Model EGFR -CE IVD - Target Selector Mutation Test Kit
From Target Selector Kits for CE Countries Only
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.
Product Details
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
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