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CE Marking for Amoy Diagnostics Co. LTD.'s EML4-ALK Test


1/2/2013 10:52:24 AM

January 02, 2013 -- Amoy Diagnostics announced today that it has obtained CE marking for its EML4-ALK Fusion Gene Detection Kit. The appropriate Declarations of Conformity have been compiled in accordance with European product safety directives. The test has also been submitted to the SFDA for approval for clinical use in mainland China. The EML4-ALK fusion oncogene represents one of the newest molecular targets in non-small-cell lung cancer (NSCLC). First described in 2007, the fusion results from a small inversion within chromosome 2p. This inversion leads to expression of a chimeric tyrosine kinase having the N-terminal portions of echinoderm microtubule-associated protein-like 4 (EML4) fused to the intracellular kinase domain of anaplastic lymphoma kinase (ALK). The EML4-ALK protein possesses potent oncogenic activity both in vitro and in vivo. This activity can be blocked by small-molecule inhibitors such as Pfizer’s Xalkori.

“The AmoyDx EML4-ALK test is a sensitive and easy-to-use molecular assay for the re-arrangement status of the ALK kinase gene, a key oncogenic event in a significant percentage of NSCLC” said David Whyte, PhD, VP of global development at Amoy Diagnostics. “Now that the test has CE marking, we anticipate expanded use of the test, in particular in countries that require CE marking for in-vitro diagnostic assays.”

The EML4-ALK kit employs proprietary real-time PCR technology to detect the 21 EML4-ALK fusion transcripts. RNA that has been purified from the FFPE tissue is first reverse transcribed to cDNA with RT enzyme supplied with the kit. The EML4-ALK fusion cDNAs are then specifically amplified with cross-junction PCR primers and qualitatively detected with fluorescent probes.

Amoy Diagnostics announced CE marking for its EGFR, KRAS and BRAF mutation detection kits in February, 2011. AmoyDx has a rich portfolio of molecular tests developed in its ISO 13485-certified laboratory. In addition to the EGFR, KRAS, BRAF and EML4-ALK tests, AmoyDx has developed and validated test kits for mutation status of JAK2, ABL, PIK3CA, KIT, PDGFRA. The portfolio also includes gene expression assays to predict chemotherapy response, including ERCC1 for platinum-based chemotherapy and RRM1 for gemcitabine therapy. New assays in the company’s pipeline include ALK 3’/5’ gene expression, and ROS1 and RET gene rearrangements assays. “Our goal is to provide a comprehensive panel of molecular tests that will quickly identify driver mutations in cancer, especially NSCLC, so that patients can receive the most appropriate treatment based on the mutation profile of their tumor”, said Dr. Whyte. The AmoyDx assays are based on proprietary technology developed in AmoyDx’s laboratory in Xiamen, China. The technology, called “ADx-ARMS”, uses a patented two-step process to detect mutations in tumor nucleic acids. The method has excellent sensitivity and accuracy, and has been validated on PCR instruments from several manufacturers, including: Roche Light Cycler 480; Stratagene Mx 3000P & 3005P; Applied Biosystems StepOnePlus, 7300, 7500 and 7900; Bio-Rad IQ5/CFX96; and the Qiagen Rotor-Gene Q.

Please see the website at http://www.amoydx.com/en for more details.

Please send inquiries to:

David Whyte, Ph.D. Email: WhyteD@AmoyDx.com Tel: Xiamen, China +86 592 6806815; Belmont, CA, USA 650-954-1055 http://www.amoydx.com/en

About Amoy Diagnostics

Amoy Diagnostics is a provider of state-of-the-art diagnostic products and services. Its customers include healthcare providers, academic institutions, and pharmaceutical companies. The company has a growing portfolio of molecular diagnostics tests for the emerging integration of personalized medicine into healthcare. These services and products are currently in the areas of oncology and bacterial infections, with developing interests in viral infections. Amoy Diagnostics' GMP manufacturing facility and ISO13485-certified labs are based in Xiamen, China. For more information about Amoy Diagnostics, please visit: www.amoydx.com/en.

Sincerely,

David B. Whyte, Ph.D.

V.P., Global Development

Amoy Diagnostics

Xiamen, China/San Francisco Bay Area, USA

Office: (86) 592-680-6815

Cell (China): (86) 182-0595-3547

Cell (USA): (01) 650-954-1055

Web: www.amoydx.com/en

Email: whyted@amoydx.com or davidbwhyte@gmail.com


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