AmoyDx and Merck Enter Companion Diagnostic Collaboration: Enhanced AmoyDx® Panel Launches Registration in Japan

Following the launch of the global colorectal cancer RAS testing project by Amoy Diagnostics and Merck Group in 2016, the two parties have recently expanded their collaboration into new areas.

Amoy Diagnostics’ announcement on the 10th disclosed that it recently signed a cooperation agreement with Merck Group. Amoy Diagnostics, based onPCRThe "Lung Cancer Multi-Gene Joint Detection Product" (i.e., the upgraded version of AiHuiJian®), independently developed by the technical platform, will be used for Merck's MET inhibitor Tepotinib in Japan.Companion DiagnosticsRegistration.

 Tepotinib is the first oral MET inhibitor approved globally for the treatment of patients with advanced non-small cell lung cancer (NSCLC) harboring MET gene mutations. It was approved for marketing by Japan’s Ministry of Health, Labour and Welfare in March this year for the treatment of NSCLC patients with MET exon 14 skipping mutations.

In recent years, lung cancer has become the most prevalent cancer in China. According to the national cancer statistics released by the National Cancer Center in January 2019, there were 784,000 new cases of lung cancer in China, with both its incidence and mortality rates ranking highest among all malignant tumors. The emergence of targeted therapies has brought hope to patients; however, since these drugs are not suitable for all patients, precise diagnosis has become the foundation for ensuring the success of personalized cancer treatment.

In current lung cancer treatment, EGFR, ALK, and ROS1 are common targets with corresponding targeted therapies, whereas MET, HER2, and RET are rare targets, with related drug development and clinical studies still ongoing. The upgraded version of AiHuiJian®, developed by Amoy Diagnostics, is a companion diagnostic product targeting the rare MET alteration.

In 2018, AiHuiJian® was approved for market launch in China. According to previous media reports, this kit is a product based on Amoy Diagnostics’ proprietary ADx-ARMS® core technology platform. It can detect key driver genes in lung cancer, including EGFR, ALK, ROS1, KRAS, BRAF, HER2, RET, MET, NRAS, and PIK3CA, integrating the detection of gene mutations and gene fusions into a single product. This enables same-day reporting while ensuring accurate results, achieving rapid, simultaneous detection of different types of genetic variations.Currently, the upgraded version of AmoyDx® has initiated the registration and approval process in Japan.

Founded in 2008, Amoy Diagnostics is China's first oncologyPrecision MedicineAs a molecular diagnostic reagent R&D enterprise, the company owns two proprietary technology platforms with independent intellectual property rights: ADx-ARMS® and Super-ARMS®. At the time of Amoy Diagnostics’ listing in 2017, its Vice President, Zhu Guanshan, stated that the company was strategically positioning itself around two major product lines of companion diagnostic reagents: one based on PCR technology and the other on next-generation sequencing (NGS) technology.

Notably, this is not the first collaboration between Amoy Diagnostics and Merck. As early as 2016, Amoy Diagnostics signed a cooperation agreement with Merck to launch the Merck-Amoy Diagnostics “Precision Testing, Precision Treatment” colorectal cancer RAS testing project. This project is dedicated to the global development and promotion of novel RAS liquid biopsy for colorectal cancer detection, as well as the promotion of tumor tissue RAS testing in mainland China.

In addition to its collaboration with Merck KGaA, Amoy Diagnostics has also partnered with numerous multinational pharmaceutical companies in recent years on companion diagnostics for targeted therapies.In June this year, Amoy Diagnostics and AstraZeneca jointly launched an agency partnership for integrated diagnostic products in lung cancer diagnosis and treatment. Leveraging their respective resource advantages, they aim to popularize lung cancer testing and diagnosis, improve the coverage and precision of such diagnostics, and promote the development of personalized lung cancer care.

In terms of products, the “Lung Cancer Multi-Gene Joint Detection Product” (i.e., the upgraded version of AmoyDx®), independently developed based on the PCR technology platform, serves as a companion diagnostic product for targeted therapies from companies such as Eli Lilly and Amgen. In the NGS platform sector, Amoy Diagnostics’ independently developed WellGen® is a companion diagnostic product for oncology portfolios from companies such as Johnson & Johnson and Eli Lilly.

This article is sourced from EO Intelligence, an original piece by author Lin Yiling. For reprinting or collaboration inquiries, please click here.Reprint NoticeUnauthorized reproduction will be subject to legal liability.