Scientists working on the development of companion diagnostics at Qiagen’s research and development (R&D) laboratory in Manchester, UK. Credit: QIAGEN.

Qiagen has launched the therascreen FGFR Kit, a companion diagnostic to identify patients that are eligible for treatment with Janssen Biotech’s fibroblast growth factor receptor (FGFR) kinase inhibitor drug Balversa.

Approved by the US Food and Drug Administration (FDA), the diagnostic is designed to identify tumours with specific alterations in the Fibroblast Growth Factor Receptor 3 (FGFR3) gene.

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To be used with Qiagen’s Rotor-Gene Q MDx automation solution, the kit examines a patient’s DNA or ribonucleic acid (RNA).

“Using our test to help guide treatment decisions in urothelial cancer will address a high unmet medical need among patients.”

Qiagen molecular diagnostics business area senior vice-president and head Thierry Bernard said: “We are very excited about the launch of the new therascreen FGFR Kit, the first companion diagnostic test to obtain FDA approval for detection of FGFR gene alterations to guide therapy in any cancer indication.

“Using our test to help guide treatment decisions in urothelial cancer will address a high unmet medical need among patients.”

Qiagen partners with pharmaceutical and biotechnology companies to create companion diagnostic tests by leveraging technologies such as next-generation sequencing (NGS) and polymerase chain reaction (PCR). The company has ongoing partnerships with more than 25 companies.

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The approval of therascreen is the sixth FDA authorisation for a treatment using the company’s companion diagnostic assay.

Approximately 15,000 people in the US are diagnosed with advanced or metastatic urothelial cancer. Some of these tumours have select FGFR alterations that are believed to be involved in tumour growth.