Servier Announces Partnership with QIAGEN to Develop New mIDH1 Companion Diagnostic Test to Support Servier’s Hemato-Oncology Portfolio.

Paris (France), March 9, 2023 – Servier today announced it has entered into a strategic partnership with QIAGEN, a leading global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life, to develop a companion diagnostic test that detects IDH1 mutations. This test will be for use with Servier’s marketed and investigational targeted treatments in Acute Myeloid Leukemia (AML).

QIAGEN and Servier are collaborating to develop a PCR-based companion diagnostic test that can be used to rapidly identify AML patients with IDH1 gene mutations. The partnership with QIAGEN will lead to the development of a specific diagnostic test for IDH1 gene mutations with a rapid turnaround time.

“We are pleased to support Servier with a companion diagnostic in their mission to propose innovative treatment for IDH1 mutated AML patients. At the same time, we are further strengthening our role in developing companion diagnostics for the ever-growing number of biomarkers being discovered in onco-hematology.”

Jonathan Arnold, Vice President, Head of Partnering for Precision Diagnostics at QIAGEN

Under the Master Collaboration Agreement, QIAGEN will develop and validate a real-time PCR-based in vitro diagnostic test that can be used to detect IDH1 gene mutations in whole blood and bone marrow aspirates in AML.

The companion diagnostic will run on the QIAGEN Rotor-Gene Q MDx device, which is widely used by labs worldwide. QIAGEN’s experienced regulatory teams will support clinical validation of the companion diagnostic and its approval in the US, the European Union and Japan.

“Early biomarker testing for an IDH1 mutation has grown in importance for targeted therapies and can play a critical role in the treatment of acute myeloid leukemia (AML).”

Fabien Schmidlin Head of Translational Medicine at Servier