EGFR Mutation Testing

Studies into non-small cell lung cancer have shown that some patients carry somatic mutations in the epidermal growth factor receptor (EGFR) tyrosine kinase gene. These mutations correlate with responsiveness to tyrosine kinase inhibitors, the mutations having a sensitising effect.

Lab21 offers the CE-Marked EGFR assay developed by DxS Genotyping, a highly selective and robust test combining Scorpions and ARMS® (allele specific PCR technologies), which detects the following EGFR mutations:

• 19 deletions in exon 19
• L858R
• L861Q
• G719X (detects the presence of G719S, G719A or G719C but does not distinguish between them)
• S7681
• 3 insertions in exon 20 (detects the presence of any of 3 insertions, but does not distinguish between them)

EGFR testing with Lab21 can maximise patient selection of likely tyrosine kinase inhibitor responders by identifying patients with sensitising mutations.

European Medicines Agency (EMEA) has approved the EGFR tyrosine kinase inhibitor gefitinib (Iressa®, Astra Zeneca) for the treatment of adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with activating mutations of EGFR across all lines of therapy.  The authorisation is based on a submission package including two pivotal Phase III studies comparing IRESSA with chemotherapy, IPASS and INTEREST.

To order the EGFR assay, please contact Lab21 EGFR customer service.

Tel:  UK 0845 6778107 International 01223 395450
E Mail: egfr@lab21.com
Fax: +44 (0)1223 395 451

References:

• Kim et al. Gefitinib versus docetaxel in previously treated non-small-cell lung cancer (INTEREST): a randomised phase III trial. Lancet 2008; 372(9652): 1809-18.
• Mok T. Phase III, Randomised, Open-Label, First-Line Study Of Gefitinib Vs Carboplatin/Paclitaxel (C/P) In Clinically Selected Patients With Advanced Non-Small-Cell Lung Cancer (NSCLC), Presented at the European Society of Medical Oncology meeting, Stockholm. Abs LBA2, 2008.
• Newton CR, Graham A, Heptinstall LE et al. Analysis of any point mutation in DNA. The amplification refractory mutation system (ARMS). Nucleic Acids Res. 1989; 17: 2503-2516.
• Whitcombe D, Theaker J, Guy SP, Brown T, Little S. Detection of PCR products using self-probing amplicons and fluorescence. Nat.Biotechnol. 1999; 17: 804-807.