AmoyDx® EGFR/ALK/ROS1 Mutations Detection Kit | 8.01.25501W008

AmoyDx® EGFR/ALK/ROS1 Mutations Detection Kit | 8.01.25501W008 | Gentaur UK, US & Europe Distribution

Lung cancer is the most common malignant tumor and the leading cause of cancer death worldwide. About 80〜85% of lung cancers are non-small cell lung cancer (NSCLC). In recent years, various molecular targeted therapies have been developed for the treatment of advanced lung cancer. Targeted therapies are potentially very effective in patients with specific gene mutations or rearrangements. The identification of multiple genetic abnormalities which drive oncogenic signaling pathways within cancer cells has led to the development of new targeted therapies in a subset of patients with NSCLC. Like EGFR mutations, ALK and ROS1 gene fusions are shown to be effective therapeutic targets of tyrosine kinase inhibitors (TKIs).

It has been reported that lung cancer patients who experienced rapid, durable, complete or partial responses to EGFR-TKIs therapy have been found to harbor somatic mutations in the EGFR gene, and the presence of the ALK and ROS1 gene fusions are correlated with the efficacy of TKI therapy (e.g., crizotinib). Based on analysis of tumor DNA and RNA, EGFR mutations, ALK gene fusions and ROS1 gene fusions can be detected by real-time PCR method.

Intended Use

The AmoyDx® EGFR/ALK/ROS1 Mutations Detection Kit is an in vitro nucleic acid amplification test intended for qualitative detection of 24 EGFR mutations (exons 18-21), 21 ALK gene fusions and 13 ROS1 gene fusions in tumor DNA/RNA extracted from NSCLC tissue samples.

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