EGFR Mutation Analysis with STA Core Reagents


The non–small cell lung cancer (NSCLC) accounts for about 85% of lung cancer, the leading cause of cancer death and the second most common cancer among both men and women in the United States. In 2013, the College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) published "Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors."1 In 2014, the American Society of Clinical Oncology (ASCO) endorsed the CAP/IASLC/AMP guideline for EGFR and ALK molecular testing.2 The most common mutations associated with sensitivity to EGFR TKIs include exon 19 deletions and the L858R point mutation.3  


Assay Advantages:

  • Uses less clinical samples –  works for small samples such as fine needle aspiration (FNA)
  • Detects low level (1-5%) mutation allele frequency
  • Results in 2 hours with sequencing-like accuracy

Target Mutations        point mutations and insertion/deletion in exons18, 19, 20 and 21

Assay Sensitivity       Detects 1-5% EGFR mutations in wild type background

Assay Format             One tube test

Assay workflow          Simple two-step protocol: PCR and Capillary Electrophoresis

Sample required        10-100 ng DNA 

Assay Platform         Capillary sequencer ABI 3100, 3700, 3130, 3500


Order Information 

Cat. No. Product NameTarget MutationsSizeDocuments
Cor-ASTA Core Reagents AUniversal Reagents for Point Mutations32 rxnProtocol
Cor-CSTA Core Reagents CUniversal Reagents for Insertions/Deletions32 rxnProtocol

For research use only. Not for use in diagnostic procedures.


Core:  Cor-A and Cor-C

DNA Primer:  GP07-01 and GP07-02


EGFR point mutation controls:

Example results with FFPE samples:




Related Products



  1. Lindeman NI et al. (2013). Molecular Testing Guideline for Selection of Lung Cancer Patients for EGFR and ALK Tyrosine Kinase Inhibitors JMD 15:415.
  2. Leighl NB et al. (2014). Molecular Testing for Selection of Patients With Lung Cancer for Epidermal Growth Factor Receptor and Anaplastic Lymphoma Kinase Tyrosine Kinase Inhibitors: American Society of Clinical Oncology Endorsement of the College of American Pathologists/International Association for the Study of Lung Cancer/Association for Molecular Pathology Guideline JCO 32:3673.
  3. Jänne PA and Johnson BE (2006). Effect of epidermal growth factor receptor tyrosine kinase domain mutations on the outcome of patients with non-small cell lung cancer treated with epidermal growth factor receptor tyrosine kinase inhibitors. Clin Cancer Res 12(14Suppl):4416s.