NEW YORK (GenomeWeb News) – Amoy Diagnostics today said that it has reached an agreement with OxOnc Development to use Amoy's ROS1 Gene Fusions Detection Kits for a pivotal clinical trial of Pfizer's Xalkori (crizotinib).
Xiamen, China-based Amoy said that it would provide the kits to the labs conducting the study in China, Korea, and Japan. It also will provide technical support for the assay, which uses real-time PCR to detect 14 different fusion products in cDNA derived from tumor tissue or body fluids.
OxOnc inked a co-development agreement with Pfizer earlier this year to conduct an open-label, single-arm study of crizotinib in East Asian patients with advanced ALK-negative non-small cell lung cancer harboring a translocation or inversion involving the ROS1 oncogene locus.
Financial and other terms of the agreement were not disclosed.
"We have five products that have received SFDA approval for clinical use in China and CE marking for IVD use in Europe, but the ROS1 assay will be the first product for which we will seek regulatory approval in Japan, South Korea and Taiwan," David Whyte, VP of global development at Amoy Diagnostics, noted in a statement.