AmoyDx® EGFR 29 Mutations Detection Kit | 8.01.20201

The epidermal growth factor receptor (EGFR) plays a central role in transmitting signals that promote cell growth and proliferation. Due to its association with malignancies, EGFR has become the target of an expanding class of anticancer therapies, such as gefitinib, erlotinib and afatinib, which are tyrosine kinase inhibitors (TKIs). The TKIs target the EGFR tyrosine kinase domain. These drugs work best on non-small cell lung cancer (NSCLC) patients whose cancer is driven by abnormal EGFR signaling. Lung cancer patients who experienced rapid, durable, complete or partial responses to TKI therapy have been found to harbor somatic mutations in EGFR gene. NSCLC patients with sensitizing EGFR mutations treated with TKI therapy have shown longer progression-free survival and higher response rate, compared with conventional chemotherapy. Resistance to TKI therapy, either in the primary tumor or acquired after TKI treatment, is associated with EGFR T790M mutation. Therefore, assessment of EGFR mutation status facilitates personalized treatment to lung cancer patients.

Intended Use

The AmoyDx® EGFR 29 Mutations Detection Kit is a real-time PCR assay for qualitative detection of 29 somatic mutations in exons 18, 19, 20 and 21 of EGFR gene in human genomic DNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue, or circulating DNA extracted from plasma/serum. The kit is intended to assess EGFR mutation status in NSCLC patients and aid in identifying patients who may respond to the treatment with an EGFR-TKI.

The kit is for in vitro diagnostic use, and intended to be used by trained professionals in a laboratory environment.