Qiagen, Germantown, Md, and Hilden, Germany, has launched the Therascreen FGFR RGQ RT-PCR kit as a companion diagnostic to help guide use of the recently approved fibroblast growth factor receptor (FGFR) kinase inhibitor Balversa (erdafitinib), developed by Janssen Biotech Inc, South San Francisco, Calif.

The test will aid in identifying patients with urothelial cancer whose tumors have certain alterations in the FGFR3 gene. FDA coapproved the new test with Balversa.

A percentage of urothelial carcinoma tumors have certain alterations in the FGFR gene which are thought to be key drivers of tumor growth. Detection of such alterations utilizing the Therascreen companion diagnostic will help identify patients eligible for treatment with Balversa.

The Therascreen FGFR kit will run on Qiagen’s Rotor-Gene Q MDx, one of Qiagen’s modular QIAsymphony family of automation platforms. The test leverages Qiagen’s worldwide exclusive license for in vitro diagnostic use of FGFR3:TACC3 fusions from Columbia University.

Thierry Bernard, Qiagen.

Thierry Bernard, Qiagen.

“We are very excited about the launch of the new Therascreen FGFR kit, the first companion diagnostic test to obtain FDA approval for the detection of FGFR gene alterations to guide therapy in any cancer indication,” says Thierry Bernard, senior vice president and head of Qiagen’s molecular diagnostics business area. “Using our test to help guide treatment decisions in urothelial cancer will address  a high unmet medical need among patients.

“The new Therascreen FGFR kit, and significant testing capacities at leading laboratories, will be available through Qiagen’s Day-One lab readiness program, to accelerate the availability of innovations in precision medicine,” Bernard adds.

For further information, visit Qiagen.

Featured image: Qiagen Therascreen FGFR RGQ RT-PCR kit.