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AmoyDx and Servier Collaborate on Companion Diagnostic Development for Diffuse Glioma in China

NextEdge Admin

27 Jun 2024

2 min 43 sec

AmoyDx, a Chinese molecular diagnostic company, and Servier, a pharmaceutical firm, have joined forces to develop a companion diagnostic test tailored for Chinese patients with diffuse glioma, specifically for Servier's experimental drug vorasidenib.

The collaborative effort aims to create a next-generation sequencing-based test capable of identifying mutations in the isocitrate dehydrogenase (IDH) 1 and 2 genes, crucial markers in patients with diffuse IDH-mutant glioma. Vorasidenib, under investigation by Servier, functions as a dual inhibitor targeting mutant forms of both IDH1 and IDH2 enzymes, marking a significant advancement in precision medicine.

The partnership outlines comprehensive objectives that include the analytical and clinical validation, manufacturing, and commercialization of the diagnostic test. AmoyDx will leverage its expertise in next-generation sequencing panels to develop the test, ensuring readiness for regulatory approval and subsequent availability upon vorasidenib's clearance in China.

Servier's global strategy extends beyond China, encompassing regulatory evaluations by major bodies like the US FDA and the European Commission, as well as Orbis member countries such as Brazil, Canada, Australia, Israel, and Switzerland. An anticipated decision from Chinese regulators is slated by 2030, underscoring the commitment to advancing treatment options for patients with diffuse glioma.

Notably, Servier has also initiated partnerships with entities in the US, Europe, and Japan to facilitate the development of companion diagnostic tests for vorasidenib, underscoring a global effort to streamline patient identification and treatment.

Fabien Schmidlin, Servier's Global Head of Translational Medicine, emphasized the pivotal role of early mutation detection in optimizing treatment outcomes for patients with IDH-mutated tumors. He highlighted the symbiotic relationship between therapeutic development and companion diagnostics, envisioning a future where tailored treatments are swiftly matched with patient needs.