China FDA Grants Liquid Biopsy Approval to AmoyDx Super-ARMS EGFR Mutation Test

(January 22, 2018, Xiamen China)  Amoy Diagnostics announced that China Food and Drug Administration (CFDA) approved its Super-ARMS® EGFR Mutation Test for use with plasma samples, as a companion diagnostic for non-small cell lung cancer (NSCLC) therapy with EGFR-TKIs on January 19. It is the first companion diagnostic kit approved by CFDA for the detection of the epidermal growth factor receptor (EGFR) gene mutations in circulating tumor DNA (ctDNA) derived from plasma. Patients with NSCLC carrying EGFR activating mutations, such as exon 19 deletions, L858R mutation, or T790M mutation, are candidates for the EGFR-targeted therapy with EGFR-TKIs.

Many patients do not have the opportunity to be selected for targeted therapies due to variable difficulties in obtaining sufficient tumor tissue for the test. The CFDA approval of the Super-ARMS® EGFR Mutation Test for use with plasma will help alleviate those barriers to molecular testing by giving clinicians more options for their patients. This unique test kit has been CE-IVD approved since April 2017.

“The development of liquid biopsy-based diagnostics in non-small cell lung cancer will transform the diagnostic workup of advanced stage patients. The ability to both isolate and genetically interrogate tumor DNA from a simple, minimally invasive test that can subsequently inform treatment decisions will benefit a lot to physician and patient,” said Prof. Yi-long Wu of Guangdong General Hospital, former President of Chinese Society of Clinical Oncology (CSCO).

“The CFDA approval of our Super-ARMS® EGFR Mutation Test for liquid biopsy for companion diagnostics sets a new standard in treating patients with NSCLC,” said Dr. Li-mou Zheng, founder and CEO of AmoyDx. “We are glad to see that the patients in China who are unable to provide tissue samples will have an opportunity to receive precision treatment. In the future we will adhere to our mission of providing customers with superior and innovative products and services to improve healthcare and patients’ lives.”

About the Super-ARMS® EGFR Mutation Test

The Super-ARMS® EGFR Mutation Test is built upon the success of the ADx-ARMS® EGFR Mutation Test available globally today, with expanded mutation coverage that identifies 41 EGFR mutations in exons 18-21, including L858R, exon 19 deletions, and T790M. The kit allows detect 0.2 ~ 0.8% mutant DNA in a background of 99.8 ~ 99.2% normal genomic DNA.

About AmoyDx

Amoy Diagnostic Co., Ltd. is an R&D based provider of state-of-the-art companion diagnostic products and services in the area of human precision oncology. The company has a rich portfolio of oncology molecular testing products which can be used for the detection of gene mutation/fusions of different cancer types including but not limited to lung cancer, colorectal cancer, breast cancer, cervical cancer and melanoma. AmoyDx is one of market leaders in the field of oncology diagnostics for precision medicines and its products have been widely used in over 50 countries.


For media inquiries please contact:

Dr. Jiemin Luo,

Back to news