1. Genetron Health Reaches Strategic Partnership with Yikon Genomics, Expanding S5 Platform’s Reach to Reproductive Health Field

Genetron Holdings Limited (“Genetron Health” or the “Company”, NASDAQ: GTH), a leading precision oncology platform company in China that specializes in offering molecular profiling tests, early cancer screening products and companion diagnostics development, today announced the signing of a strategic partnership with Shanghai Yikon Genomics Technology Co., Ltd. (“Yikon Genomics”), a company that focuses on reproductive health diagnostic testing. Genetron Health expects this partnership to contribute to its 2021 revenues.

Under the agreement, Yikon Genomics will have the exclusive rights to use Genetron Health’s S5 instrument for reproductive health applications in the China market. Yikon Genomics currently offers pre-pregnancy, prenatal and inheritance disorder testing solutions for a network of over 400 hospital partners in China. The partners will cooperate with each other to drive forward registration processes for new assays that are developed on the S5 platform. Genetron Health will also support Yikon Genomics’ commercialization efforts. GENETRON S5 has been successfully used in many different oncology settings, and through this partnership, will be expanding its applications to include reproductive health, widening the Company’s scope of precision medicine.

Approved by the NMPA in 2019 and based on new semiconductor sequencing technology, GENETRON S5 is China’s desktop, clinical-grade, medium-throughput next generation sequencing (NGS) platform. GENETRON S5’s advantages lie in its fast detection, flexible throughput, low initial sample size requirements, and comprehensive range of different applications. Genetron Health has used this platform to develop in-vitro diagnostic (IVD) kits that cover multiple cancer types and different sample types, including the 8-gene Lung Cancer (Tissue) assay. With GENETRON S5, the Company has developed an integrated solution for molecular diagnostics laboratories, and carried out clinical trials and scientific research partnerships with many different organizations. These efforts have enabled hospitals in China to adopt NGS technology for independent, clinical diagnostic use.

2. AmoyDx Collaborates with Amgen to Develop Companion Diagnostics for Japan Market

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.” 

3. AcornDx Collaborates with BGI to Develop Accurate Diagnosis on Urinary System Tumors

On August 19, 2021, Beijing AcornDx Biotechnology Co., Ltd. and BGI officially announced the strategic cooperation. The two sides will work together to carry out in-depth cooperation in the field of accurate diagnosis and treatment of urinary system tumors, aiming to jointly promote the development of the whole process one-stop platform based on gene detection of urinary system tumors. AcornDx will develop localized whole process solutions for urinary system tumors based on BGI` s high-throughput sequencing platform mgiseq-2000. BGI will continue to provide high-quality supporting products and services for AcornDx to meet the needs of its clinical testing product development.