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AmoyDx Collaborates with Amgen to Develop Companion Diagnostics for Japan Market

Xiamen, China, Aug 19, 2021 - Amoy Diagnostics Co., Ltd. (AmoyDx, SZSE: 300685), an innovative commercial-stage in vitro diagnostic (IVD) company, and Amgen Inc. (NASDAQ: AMGN), announced today that the companies have entered into a strategic collaboration to develop a Companion Diagnostic (CDx) kit in Japan, supporting sotorasib, a novel small molecule that specifically and irreversibly inhibits KRAS G12C in patients with Non-Small Cell Lung Cancer, approved by FDA in May, 2021. The CDx test is based on AmoyDx’s industry-leading PCR platform.

Under the terms of the collaboration, AmoyDx will develop its CDx kit: AmoyDx® Pan Lung Cancer PCR Panel (AmoyDx® PLC Panel) which has been approved by PMDA in June 2021, for a further extended use as a follow-on CDx for sotorasib.

The AmoyDx® PLC Panel provide fast, accurate and sensitive molecular results that enable efficient diagnosis for genomic screening on a regional scale of patients. This CDx kit has been assessed by NCC East (National Cancer Center East) as well as the major clinical institutions in Japan, it is also accepted into LC-SCRUM-Asia as screening test for pharma trials in Japan1.

“AmoyDx is a leading company in the field of precision oncology focusing on companion diagnostics. It owns rich experience in developing diagnostic solutions and global commercialization of precision medicines. We are very glad to form partnership with AmoyDx to prepare great Dx solutions for sotorasib”, said Yukihito Kuwagaki, Japan Head of Medical Development at Amgen K.K.

“We announce with great excitement this collaboration with Amgen on sotorasib for the Japan market” said Li-Mou Zheng, Ph.D., Founder and CEO of AmoyDx. “AmoyDx has a strong pipeline of diagnostic products for precision medicines. Exploiting our test to help guide treatment decisions will address a high unmet medical need from patients. AmoyDx is a trusted partner with the expertise in R&D, Regulatory Affairs and Commercialization for co-development of companion diagnostic.” 


About Amoy Diagnostics Co., Ltd.

Amoy Diagnostics Co., Ltd. (SZSE: 300685) is a Chinese leading biotech firm which pioneered the development and commercialization of cancer diagnostics in China. It is the largest provider of molecular diagnostics products for personalized healthcare in China, as well as a service center for oncology biomarker analysis. AmoyDx is also actively deploying the commercial application of cancer Dx in Asian and global markets. AmoyDx has a market-leading portfolio of molecular tests and is the therapy diagnostics partner for several major multinational pharmaceutical companies offering precision therapies for cancer.

Contact: For more information, please call us at +86-592-6806835 or email us at


About Amgen Inc.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology.

Amgen focuses on areas of high unmet medical need and leverages its expertise to strive for solutions that improve health outcomes and dramatically improve people’s lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world’s leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential.

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