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Amoy Diagnostics Co. LTD. to Supply ROS1 Diagnostic Kits for Pivotal Clinical Trial of Crizotinib in Asia


8/29/2013 9:03:56 AM

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August 27, 2013, Xiamen, China- Amoy Diagnostics Co, Ltd. (“AmoyDx”) today announced that it has entered into an agreement with OxOnc Development LP, (“OxOnc”) to provide AmoyDx ROS1 Gene Fusions Detection Kits for a pivotal clinical trial of Pfizer's crizotinib, marketed under the trademark Xalkori®. ROS1 rearrangements define a molecular class of lung cancers that may respond to crizotinib1. On February 8, 2013, OxOnc announced that it entered into a co-development agreement with Pfizer to conduct an open-label, single-arm study (the “Study”) of the efficacy and safety of crizotinib in East Asian patients with advanced ALK-negative non-small cell lung cancer (NSCLC) harboring a translocation or inversion involving the ROS1 oncogene (ROS1) locus. The Study will be conducted at multiple sites in Japan, China, Taiwan and South Korea.

Under the terms of the Amoy-OxOnc agreement, Amoy Diagnostics will provide ROS1 Gene Fusions Detection Kits to the Study’s central clinical laboratories in China, Korea and Japan where the tests will be performed, as well as technical support for the assay. Data generated from the Study will enable the submission of the AmoyDx ROS1 assay for approval by regulatory authorities in Japan, China, South Korea, and Taiwan.

"We are very pleased to partner with OxOnc to provide ROS1 companion diagnostic kits for this pivotal clinical trial of crizotinib in Asia”, said David Whyte, Ph.D. VP of Global Development at Amoy Diagnostics. “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.”

The ROS1 assay uses real-time PCR to detect 14 different fusion products in cDNA derived from tumor tissue or body fluids and has been validated on PCR instruments from several manufacturers.

About Amoy Diagnostics:

Amoy Diagnostics is a provider of state-of-the-art diagnostic products and services in the area of human oncology. Its customers include healthcare providers, academic institutions, and pharmaceutical companies. The company has a growing portfolio of molecular diagnostics tests including EGFR, EML4-ALK, KRAS, BRAF and PIK3CA mutation detection kits that have received Chinese FDA approval. Amoy Diagnostics' GMP manufacturing facility and ISO13485-certified labs are based in Xiamen, China.

About OxOnc:

OxOnc Development LP is an oncology development company founded by pharmaceutical development executives and oncology experts. The OxOnc partners have extensive experience in building and managing oncology research networks in Europe and Asia and in managing global contract research organizations to optimally design and execute clinical trials. Additional information is available at: www.oxonc.com.

1. ROS1 rearrangements define a unique molecular class of lung cancers. Bergethon K, et al, J Clin Oncol. 2012 Mar 10;30 (8):863-70.

CONTACT:

David Whyte, Ph.D.

VP Global Development

Amoy Diagnostics Co, Ltd

Xiamen, China

Belmont, CA, USA

T: 1-415-830-4343

F: 1-650-637-8718

Website: http://www.amoydx.com/en.

Email: whyted@amoydx.com

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