AmoyDx and Servier Enter into a Collaboration to Develop an IDH1/2 Companion Diagnostic Test for Diffuse Glioma in China

Original from: AmoyDx

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. ​

Source: AmoyDx and Servier Enter into a Collaboration to Develop an IDH1/2 Companion Diagnostic Test for Diffuse Glioma in China