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AmoyDx and Servier Enter into a Collaboration to Develop an IDH1/2 Companion Diagnostic Test for Diffuse Glioma in China
Xiamen, China, June 25th, 2024 – AmoyDx, a China-based innovative molecular diagnostics company, and Servier, an independent international pharmaceutical group, announced today they have entered into a strategic partnership to develop a companion diagnostic test (CDx) in China that detects Isocitrate Dehydrogenase (IDH) 1&2 gene mutations. This test will be developed for vorasidenib, Servier’s investigational dual inhibitor of mutant IDH1 and mutant IDH2 enzymes, for Chinese patients with diffuse IDH-mutant glioma (LGG). 

“We are pleased to support Servier with an NGS (Next-generation sequencing)-based companion diagnostic with the ambition of providing an innovative treatment for IDH1& 2 mutated diffuse glioma patients in this region. This is our mission in common – to contribute to meeting the patient's needs by developing precision medicines and diagnostics.” Limou Zheng, Founder and Chairman at AmoyDx.

" As an innovative p in the field of IDH-mutated tumors, we are fully convinced that early detection of IDH 1 & 2 mutations play a critical role in the treatment of patients suffering from diffuse glioma,” explains Fabien Schmidlin, Global Head of Translational Medicine at Servier. “The development of a therapy and the associated companion diagnostic test are two parallel highways that are connected to each other providing the right patient with the right treatment faster. Thanks to our global footprint, we collaborate with partners, like AmoyDx, sharing the similar vision to accelerate the development of innovative therapeutics and diagnostic tests, respectively, in order to expand patients’ access to medicines, hence improving their treatment outcomes.” 

The collaboration agreement between AmoyDx and Servier is established for the development of the companion diagnostic test for vorasidenib. The overall ive is the development, analytical validation, clinical validation, approval, manufacture, and ultimate commercialization of a CDx for use in China mainland clinical trials as an aid in identifying potential responders to vorasidenib, selecting patients to be treated with the drug, and providing information for the safe and effective use of the drug. AmoyDx will use its self-developed NGS panel to develop the companion diagnostic test for vorasidenib, and to guarantee the registration and the commercial availability in China at the time of the first approval for vorasidenib. 

Companion diagnostic tests aim to define sub-populations of patients likely to respond favorably to a treatment, thanks to the identification of predictive biomarkers in patients. It guarantees not only the efficacy, but also the safety of the treatment for the patient. They also lead the way to precision medicine by identifying faster the patients who might most positively respond to a given treatment. 

Procedures for evaluating vorasidenib are underway at the FDA (Food and Drug Administration), The European Commission and Orbis member countries, including Brazil, Canada, Australia, Israel and Switzerland. For China, this decision is expected by 2030.

Through this partnership, Servier demonstrates its constant ambition to provide patients around the world with better access to precision medicine. In order to make companion diagnostic tests accessible and thus provide patients with better care, Servier has also signed partnerships in the USA, in Europe and Japan to develop companion diagnostic tests adapted to the specific needs of these geographic areas. 

About Glioma
Adult-type diffuse gliomas represent approximately 81% of primary malignant brain tumors. Of those, approximately 20% harbor an IDH mutation, including 100% of grade 2 and grade 3 adult-type diffuse gliomas, as well as a much smaller portion of the grade 4 tumors.1,2 Establishing the IDH mutation status of these tumors is essential to both diagnosis and prognosis, per the 2021 WHO (World Health Organization) classification of CNS (Central Nervous System) tumors and the NCCN (National Comprehensive Cancer Network) treatment guidelines, respectively. As of 2021, adult-type diffuse gliomas are sub-divided into only three categories:
•    Astrocytoma, IDH-mutant (CNS WHO grades 2-4)
•    Oligodendroglioma, IDH-mutant and 1p19q-codeleted (CNS WHO grades 2-3)
•    Glioblastoma, IDH-wildtype (CNS WHO grade 4) 

About Servier  
Founded to serve health, Servier is a global pharmaceutical group governed by a Foundation that aspires to have a meaningful social impact, both for patients and for a sustainable world. With its unique governance model, it can fully serve its vocation with a long-term vision: being committed to therapeutic progress to serve patient needs. The 21,900 employees of the Group are committed to this shared vocation, source of inspiration every day.  
As a world leader in cardiology, Servier’s ambition is to become a focused and innovative p in oncology by targeting rare cancers. That is why the Group allocates over 70% of its R&D budget to developing targeted and innovative therapies in oncology.  
Neuroscience and immuno-inflammatory diseases are the future growth drivers. In these areas, Servier is focused on a limited number of diseases in which accurate patient profiling makes it possible to offer a targeted therapeutic response through precision medicine.  
To promote access to quality care for all at a lower cost, the Group also offers a range of quality generic drugs covering most pathologies, relying on strong brands in France, Eastern Europe, Brazil and Nigeria.  
In all these areas, the Group includes the patient voice at each stage of the life cycle of a medicine. 
Headquartered in France, Servier relies on a strong geographical footprint in over 150 countries and achieved a revenue of €5.3 billion in 2023.  More information on the new Group website: 
About Amoy Diagnostics 
Amoy Diagnostics Co., Ltd. is a pioneer and globally leading company in molecular diagnostics for precision oncology, focusing on companion diagnostics product development and commercialization. A rich product portfolio has been established with more than 26 products approved by China NMPA, EU authority, Japan MHLW, South Korea MFDS, etc. Patients in more than 70 countries are benefiting from AmoyDx products. With multiple technological platforms and full capability for companion diagnostics product development and commercialization, AmoyDx has become an important diagnostics partner of many pharmaceutical companies all over the globe.

Press Contacts
Servier Group (Global):



1Neuro Oncology. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Accessed February 2024.

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