Updated on 21 March 2013
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 one percent to two percent 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, Amoy Diagnostics. "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 mutations."
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.