Amoy Diagnostics announced that its AmoyDx ROS1 test successfully supported OxOnc Development LP (“OxOnc”) in the completion of a Phase II study of crizotinib (the “OxOnc Study”) in East Asian patients with ROS1-positive metastatic non-small cell lung cancer (NSCLC).
The OxOnc Study met its primary objective of demonstrating a high overall response rate for crizotinib. It enrolled 127 ROS1-positive patients in the People’s Republic of China (PRC), Japan, Taiwan and South Korea by using AmoyDx® ROS1 gene fusions test, and is the largest ROS1-positive NSCLC cohort reported to date.
Results from the OxOnc Study were presented at the recent 2016 American Society of Clinical Oncology (ASCO) Annual Meeting. ROS1 gene rearrangements occur in about 2.4 percent of Asian patients with NSCLC. An estimated 1.5 million new cases of NSCLC are diagnosed worldwide each year.
"We expect NSCLC patients with ROS1 translocations to benefit significantly from the OxOnc Study results. AmoyDx aims to provide our customers with superior and innovative products and services to improve healthcare and patient well-being, and in particular, contribute to the development of new cancer therapies and precision medicine," said Dr. Zheng, AmoyDx’s CEO and President.
"We are pleased to collaborate with AmoyDx, and appreciate the excellent performance of the ROS1 diagnostic test which was critical to the success of our study completion," said Dr. Wenn Sun, OxOnc’s Managing Partner.
In February 2013, OxOnc announced that it had entered into a co-development agreement with Pfizer to conduct the OxOnc Study.
AmoyDx has obtained CE-mark for its ROS1 kit detecting 14 ROS1 gene fusions in Europe in November 2013 and received Chinese FDA (CFDA) approval in September 2014.
This highly sensitive assay uses real-time PCR technology to analyze tumor messenger RNA from human tumor tissue or tumor cells and can derive results within 2.5 hours. For NSCLC precision medicine, AmoyDx also provides EGFR, KRAS, BRAF, ALK, ALK/ROS1, EGFR/ALK/ROS1 detection kits, which are both CE certified and CFDA approved.