New Lung Cancer Mutation Panel from Amoy Diagnostics Co. LTD.

September 20, 2011 -- Amoy Diagnostics announced today the commercial availability of a new lung cancer mutation panel. The panel will test for mutations in EGFR (29 mutations), EML4-ALK (nine rearrangements), KRAS (seven mutations), and BRAF (V600E). The EGFR, KRAS and BRAF tests are CE marked for IVD use in Europe, and are also approved for clinical use in China. The EGFR test is the same one used by AstraZeneca in China to screen lung cancer patients for predicted response to Iressa. SFDA approval and CE-marking for EML4-ALK are in progress.

“The lung cancer mutation panel allows the definitive identification of mutations in four key oncogenes associated with response or resistance to targeted therapy”, said David Whyte, PhD, VP of Global Development at Amoy Diagnostics. “The kit provides a wealth of information about the molecular genetics of each cancer sample. Together, mutations in these four genes are found in about half of non-small cell lung cancer (NSCLC) samples.”

The tests are based on a proprietary real-time PCR technology, called "ADx-ARMS", which employs a patented two-step amplification method to achieve a sensitivity of 1% and accuracy of 99%.

The lung cancer mutation panel is the latest addition to AmoyDx’s menu of tests, which includes over 20 kits to detect mutations and measure gene expression in cancer tissue. Other mutation assays include PIK3CA (5 mutations), RET (14 rearrangements), PDGFRA (D842V), JAK2 (V617F), ABL1 (T315I), TP53, and KIT (D816V). AmoyDx also provides gene expression tests that help predict response to chemotherapy: ERCC1, RRM1, TYMS, TYMP, DPYD, TUBB3 and STMN1. Kits include beta-actin primers for determining relative expression, as well as standards for calculating mRNA copy number.

About Amoy Diagnostics

Amoy Diagnostics is a provider of state-of-the-art diagnostic products and services. Its customers include pathology laboratories, academic institutions, and pharmaceutical companies. The company has a growing portfolio of molecular diagnostics tests for the emerging integration of personalized medicine into healthcare. Amoy Diagnostics' GMP manufacturing facility and ISO13485-certified labs are based in Xiamen, China. The company has a strong sales force in mainland China, and has shipped diagnostic kits internationally to over 20 countries.

Please send inquiries to:

David Whyte, Ph.D.


2623 Barclay Way, Belmont, CA, 94002, USA


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