The approval allows AmoyDx to market the KRAS test for clinical use in China. This marks an industry first: the KRAS kit is the first molecular diagnostics assay to receive approval in China for use in personalized clinical testing in the area of oncology.
The assay is 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 genetic changes, or mutations, in the KRAS gene. The method has outstanding sensitivity and accuracy, and has been validated on PCR instruments from several manufacturers (see below). The KRAS test kits are assembled in AmoyDx’s GMP-certified manufacturing plant. KRAS mutations occur in colorectal and lung adenocarcinomas, as well as cancers derived from other tissues. Based on the results of this test, the patient’s healthcare providers can rationally choose the best treatment course for the patient. This is an example of the new science of “personalized medicine”, in which treatment choices are made based on the molecular profile of the patient’s tumor.
“This is significant because it is the first molecular diagnostics test to be approved in China for use in personalized clinical testing for cancer patients” said Dr. David Whyte, executive VP of Global Operations,
“More importantly, it is a new tool for physicians and other health care providers to help them make more informed decisions on how best to combat their patients’ cancers”.
“Cancer is the number one cause of death in China”, said Dr. Zheng, president of Amoy Diagnostics.
“We are proud that our company has developed a test that can shed light on the molecular mechanisms driving growth of individuals’ tumors”. AmoyDx has also developed and validated test kits for EGFR and BRAF mutations based on the ADx ARMS technology. SFDA approvals for the EGFR and BRAF tests are anticipated soon.
The company has also applied in Europe for CE marks for the KRAS, EGFR and BRAF tests.
AmoyDx has developed procedures for KRAS testing using the following machines:
Roche Light Cycler 480 I & Light Cycler 480 II; Stratagene MX 3000P & 3005P; Applied Biosystems StepOnePlus, 7300 & 7500; Bio-Rad IQ5 & CFX96.
AmoyDx has a rich pipeline of molecular tests that are being developed in its ISO 13485-certified laboratory.
The portfolio of tests focuses on activating mutations in the EGFR pathway, chemotherapy response, and infectious disease.
Please see the website at http://www.amoydx.com/en/index.php for more details.
