Droplex EGFR Mutation Test v2

Detection of the 107 defined mutations within the epidermal growth factor receptor (EGFR) gene

Features

Lung Cancer is a leading cause of cancer deaths, making up almost 25 % of all cancer deaths. About 80~85 % of lung cancer are Non-Small Cell Lung Cancer (NSCLC) – NSCLC patients are likely to have EGFR mutation, which hinders cancer treatment. The CE-IVD certified Droplex EGFR Mutation Test v2 detects 107 defined mutations within the epidermal growth factor receptor (EGFR) gene using Digital DropletTM Technology. This companion diagnostic test helps identify lung cancer patients who are eligible for tailored treatment.

BIOTYPE is the exclusive distributor of the Droplex Test Series in Germany. Legal manufacturer of the kits is GENCURIX, Inc.

Biomarkers

Exon 18: L718X, G719X, G724S

Exon 19: Ex19Del

Exon 20: S768I, T790M, Ex20Ins, C797X

Exon 21: L858R, L861Q

Product specifications

  • Cat. No.
  • CD002
  • Cancer type
  • Non-Small Cell Lung Cancer
  • Regulatory status
  • CE-IVD
  • Compatible sample type
  • DNA from FFPE tissue, cfDNA from Plasma
  • Mutation variants
  • 107
  • Kit size/reactions
  • 16 samples/kit (6 well-reactions/sample)
  • Platform
  • Digital DropletTM PCR

Resources

Instructions for Use / Handbooks
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Instructions for Use / Handbooks
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Safety Data Sheets / Non-Hazardous Statements
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Non Hazardous Statements
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Technical Information
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Ordering Information

Droplex EGFR Mutation Test v2

Kit size: 16 samples/kit (6 well-reactions/sample)
Cat. No.: CD002
Status: CE-IVD

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