AmoyDx HER2 Mutation Test Acting as Companion Diagnostics for Boehringer Ingelheim's Afatinib Study in NSCLC Patients
Date:2017-02-14Source: AmoyDx

Recently Boehringer Ingelheim launched a Phase II study of Afatinib (Identifier: NCT02597946) to evaluate its efficacy and safety in advanced patients with advanced Non-Small Cell Lung Cancer (NSCLC) harboring HER2 mutation(s) and have previously been treated with chemotherapy. The study is an international multi-centered, single arm, open-label trial, and plans to enroll 40 eligible patients from China and Southeast Asia.
AmoyDx® HER2 Mutation Detection Kit, a real-time PCR test manufactured by Amoy Diagnostics Co., Ltd., will be used for HER2 mutation status assessment as companion diagnostics for Afatinib’s clinical trial.
AmoyDx® HER2 Mutation Detection Kit is a highly sensitive assay for identifying of 13 HER2 mutations in exons 19 and 20, which uses ADx-ARMS technology, allows detection of 1% mutant DNA in a background of wild-type genomic DNA. It provides results within 90 minutes, and has been validated on several PCR platforms.

Afatinib is an irreversible covalent inhibitor of the receptor tyrosine kinases Epidermal Growth Factor Receptor (EGFR) and erbB-2 (HER2). It has received regulatory approval for use as first-line treatment of patients with EGFR mutated NSCLC in the United States, the European Union, Japan and some other countries. HER2 mutations in NSCLC are rare, being found in approximately 2-4% of lung adenocarcinomas.

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