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Servier, Qiagen to Develop PCR-Based Companion Diagnostic to Identify IDH1-Mutant Leukemia

NEW YORK – Servier and Qiagen on Thursday announced a partnership to develop a companion diagnostic test to detect acute myeloid leukemia patients whose cancers harbor IDH1 mutations, making them eligible for Servier's approved and investigational targeted therapies.

The collaboration, which the firms hope will result in a PCR-based assay to rapidly identify IDH1 gene mutations, comes in the wake of positive data from Servier's Phase III AGILE trial, in which frontline treatment with Servier's Tibsovo (ivosidenib) plus chemotherapy benefited IDH1-mutated AML patients versus chemotherapy alone.

For its part of the collaboration, Qiagen will develop and validate a real-time PCR-based in vitro diagnostic test to identify IDH1 mutations in whole blood and bone marrow aspirates. The diagnostic will use Qiagen's Rotor-Gene Q MDx device, which many labs already use routinely. Qiagen will work to validate the test for companion diagnostic approval in the US, EU, and Japan.

Based on the AGILE trial, the US Food and Drug Administration approved Tibsovo plus chemo for newly diagnosed IDH1-mutated AML patients last year. The European Medicines Agency recommended an approval following suit in Europe last month.

Tibsovo is also approved for certain patients with IDH1-mutated bile duct cancers, for which the FDA has approved Thermo Fisher Scientific's Oncomine Dx Target Test as a companion diagnostic to identify IDH1 mutations.