Therapy Areas: Devices
Qiagen Teams with Pharma Group Servier to Develop Companion Diagnostic for Acute Myeloid Leukemia Therapy Drug
14 March 2023 - - Netherlands-based molecular testing solutions provider Qiagen N.V. (NYSE: QGEN) (Frankfurt Prime Standard: QIA) has entered into a strategic partnership with pharmaceutical group Servier to develop a companion diagnostic test for TIBSOVO, an isocitrate dehydrogenase-1 inhibitor indicated for the treatment of the blood cancer acute myeloid leukemia.

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

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.

AML is a hard-to-treat cancer of the blood and bone marrow. IDH1 mutations are present in about 6 to 10 % of cases1. One of the most common types of leukemia in adults, the disease often occurs in patients in their late 60s or older.

Qiagen is in precision medicine and a leader in collaborating with pharmaceutical and biotechnology companies to develop companion diagnostics.

These can detect genetic abnormalities to provide insights that guide clinical decision-making about treatments.

From polymerase chain reaction and digital PCR to next-generation sequencing, Qiagen offers an unmatched breadth of technologies, which means it can tailor products to partners' needs.

Qiagen has master collaboration agreements to develop and commercialize companion diagnostics with more than 30 global companies a deep pipeline that will advance so-called precision medicine, which tailors a patient's treatment to the genetic profile identified by companion diagnostics testing.

Qiagen currently has eleven PCR-based companion-diagnostics tests that have been approved by the US Food and Drug Administration.

Furthermore, the company announced collaborations with Neuron23 and Helix to develop companion diagnostics in disease areas outside oncology.

Qiagen N.V., a Netherlands-based holding company, is a global provider of Sample to Insight solutions that enable customers to gain valuable molecular insights from samples containing the building blocks of life.

As of September 30, 2022, Qiagen employed more than 6,200 people in over 35 locations worldwide.