Qiagen and Servier have entered a strategic collaboration for the development of a new companion diagnostic test for isocitrate dehydrogenase-1 (IDH1) inhibitor, Tibsovo, which is indicated to treat the blood cancer acute myeloid leukaemia (AML).
Under the deal, Qiagen will develop and validate a new real-time in vitro polymerase chain reaction (PCR)-based diagnostic test.
The test will be used for the detection of IDH1 gene mutations in whole blood and bone marrow samples from patients with AML.
It will be used with the marketed and investigational targeted treatments of Servier.
Qiagen Partnering for Precision Diagnostics head and vice-president Jonathan Arnold said: “Patients with AML may deteriorate rapidly if not treated quickly so 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-haematology.”
The new test will run on the Qiagen Rotor-Gene Q MDx device, which is said to be widely used in laboratories around the world.
Clinical validation and approval of the diagnostic in Japan, the European Union and the US will be supported by Qiagen’s regulatory teams.
Servier Companion Diagnostics global head Brian Lockhart said: “In order to expand the global access for Tibsovo for patients, it is imperative that we leverage a partner, such as Qiagen, with an established global footprint in oncology-driven diagnostics, and a proven expertise in companion diagnostics development and approvals.”
Qiagen currently has master collaboration agreements with more than 30 companies for the development and commercialisation of companion diagnostics.