EGFR Mutation Detection Kit
(Based on real-time PAP nucleic acid amplification)

【Intended use】

Up to 60% of non-small cell lung cancer patients harbor somatic EGFR mutations, particularly in non-smokers, females and Asians. The therapy effectiveness of Iressa, Tarceva, Erbitux and Vectibix is closely associated with the mutation status of the EGFR gene that encodes a tyrosine kinase receptor protein.   

This kit detects eleven common mutations in exons 19, 20 and 21 of the EGFR gene in non-small cell lung cancer patents. Mutations with relative frequency ≥0.79% are included (Table 1).

The kits can be used for 1) early screening and early diagnosis of cancer, 2) early monitoring of cancer relapse, 3) early discovering and monitoring of acquired drug resistance, and 4) selection of targeted therapy.

【Detection principle】

This kit uses pyrophosphorolysis activated polymerization (PAP）technology to specifically amplify the mutant DNA but not wildtype DNA molecules. The amplified product is measured in real time fluorescence format.

【Samples】

Fresh and frozen tissues, paraffin-embedded tissues, plasma and urine.

【Advantages】

1. High sensitivity: ability to detect a single copy of KRAS mutations.

2. High specificity: virtually no false positive amplifications even in the presence of heavy background of wildtype DNA.

3. Freeze-dried format: much earlier and user-friendly manipulation.

4. Non-invasive sampling: plasma and urine samples can be applied.