CE Marking for Amoy Diagnostics Co. LTD.'s EML4-ALK Test
Published: Jan 02, 2013
“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.
David B. Whyte, Ph.D.
V.P., Global Development
Xiamen, China/San Francisco Bay Area, USA
Office: (86) 592-680-6815
Cell (China): (86) 182-0595-3547
Cell (USA): (01) 650-954-1055
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