March 20, 2013 -- Amoy Diagnostics Co., LTD, announced today that its EML4-ALK Fusion Gene Detection Kit received
market approval from China's State Food and Drug Administration (SFDA). The SFDA is the competent
authority for regulating drugs and in vitro diagnostics in mainland China. The approval allows AmoyDx
to market the EML4-ALK Fusion Detection test for clinical use in China.
Amoy Diagnostics announced CE marking for the EML4-ALK Fusion Detection kit earlier, in January of
The assay detects 21 different fusion products from rearrangements of the EML4 and ALK genes. The test
has excellent sensitivity and accuracy, and has been validated on PCR instruments from several
manufacturers (see below). The test kits are assembled in AmoyDx’s ISO13485-certified, GMP-compliant
The EML4-ALK fusion oncogene represents one of the newest molecular targets in non-small-cell lung
cancer (NSCLC). 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.
Amoy Diagnostics is the major provider of EGFR mutation detection kits in China, where it is used in over
100 hospitals. The kits are used to identify non-small cell lung cancer patients who will benefit from
treatment with anti-EGFR drugs such as Iressa or Tarceva. The company is partnered with AstraZeneca in
China to promote molecular testing of lung cancer samples so that patients receive the most appropriate
In addition to the EML4-ALK test, the AmoyDx EGFR, KRAS, BRAF and PIK3CA mutation detection kits
are also SFDA approved for clinical use in China and have CE marking for IVD use in Europe. Molecular
tests for rearrangements of the ROS1 and RET genes, found in 1% to 2% of NSCLC, are currently in
clinical trials in China, and will be submitted for CE marking and SFDA for approval later this year. The
company’s portfolio also includes gene expression assays to predict chemotherapy response, including
ERCC1 for platinum-based chemotherapy and RRM1 for gemcitabine therapy.
“Our goal is to provide a comprehensive panel of molecular tests that will quickly and reliably identify
driver mutations in cancer tissue so that patients can receive the most appropriate treatment based on the
mutation profile of their tumor”, said Dr. David Whyte, VP of Global Development. “We believe firmly
that real-time PCR is the technology of choice for therapeutic target identification, due to its ease of use
and high sensitivity. In a matter of a few hours we can go from FFPE tissue to purified nucleic acid to
actionable clinical information. This process can be readily scaled to include newly discovered driver
The assays are based on proprietary technology developed in Amoy Diagnostic’s laboratory in Xiamen,
China. The technology 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 LightCycler 480; Stratagene Mx 3000P & 3005P; Applied Biosystems
StepOnePlus, 7300, 7500 and 7900; Bio-Rad IQ5/CFX96; and the Qiagen Rotor-Gene Q. The kits are
shipped via FedEx, DHL or other carriers to laboratories in over 30 countries.
For a list of articles that describe work performed with Amoy Diagnostics products, please visit:
Please send inquiries to: David Whyte, Ph.D. Email: Info@AmoyDx.com Tel: Xiamen, China +86 592
6806835; 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 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 for
the emerging integration of personalized medicine into healthcare. Amoy Diagnostics' GMP
manufacturing facility and ISO13485-certified labs are based in Xiamen, China.