“The CE marking for these products opens up whole new markets for us” said David Whyte, PhD, VP of global development at Amoy Diagnostics. “They represent a significant milestone in our development as a global company”.
The AmoyDx EGFR assay tests for somatic gain-of-function mutations in the tyrosine kinase domain that are associated with sensitivity to small-molecule kinase inhibitors such as Iressa. Iressa is a first-line treatment for EGFR mutation-positive advanced non-small cell lung cancer made by AstraZeneca.
AmoyDx is a supplier of EGFR mutation detection kits for AstraZeneca in China. AmoyDx and AstraZeneca are collaborating to train oncologists, thoracic surgeons, pathologists and other hospital staff in China to use AmoyDx’s EGFR mutation detection kits to profile EGFR status in non-small cell lung cancer samples.
The AmoyDx BRAF test detects the mutation that causes the V600E amino acid substitution in the BRAF protein. The BRAF V600E mutation is found predominantly in malignant melanoma, sporadic colorectal tumors showing mismatch repair defects in microsatellites, low-grade ovarian serous carcinoma and thyroid papillary cancer. Therapeutic agents targeting activated BRAF are in development in a number of companies.
The AmoyDx KRAS test detects the seven most common activating mutations of the KRAS gene in cancer tissue. KRAS mutations occur in colorectal and lung adenocarcinomas, as well as cancers derived from other tissues.
AmoyDx has a rich pipeline of molecular tests that are being developed in its ISO 13485-certified laboratory. In addition to the EGFR, KRAS and BRAF tests AmoyDx has developed and validated test kits for mutation status of JAK2, ABL, PIK3CA, KIT, PDGFRA and P53 genes. The portfolio of tests includes gene expression assays to predict chemotherapy response: ERCC1 for platinum-based chemotherapy, TYMS for 5-FU based chemotherapy, and RRM1 for Gemcitabine therapy. The company also offers RT-PCR tests for Chlamydia and Uu infections.
The 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 DNA. The method has excellent sensitivity and accuracy, and has been validated on PCR instruments from several manufacturers, including: Roche Light Cycler 480 I & Light Cycler 480 II; Stratagene MX 3000P & 3005P; Applied Biosystems StepOnePlus, 7300, 7500. All of the RT-PCR assays are currently being validated on the ABI 7900 instrument.
Custom assays can also be designed, manufactured and packaged in a wholly-owned GMP-compliant ISO13485-certified facility. 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 AstraZeneca
AstraZeneca is a major international healthcare business engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and supplier for healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with healthcare sales of US$ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. For more information about AstraZeneca, please visit: www.astrazeneca.com
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.
