Qiagen Korea said on Friday it received domestic approval from the Ministry of Food and Drug Safety for Korea's first companion diagnostic (CDx) that can detect FGFR 3 (fibroblast growth factor receptor 3) gene mutations in urothelial cancer patients.

Qiagen Korea received domestic approval from the Ministry of Food and Drug Safety for Korea's first companion diagnostic (CDx) that can detect FGFR 3 (fibroblast growth factor receptor 3) gene mutations in urothelial cancer patients.
Qiagen Korea received domestic approval from the Ministry of Food and Drug Safety for Korea's first companion diagnostic (CDx) that can detect FGFR 3 (fibroblast growth factor receptor 3) gene mutations in urothelial cancer patients.

On the same day, the MFDS approved Janssen Korea’s orphan drug, Balversa, for treating urothelial cancer. 

Qiagen’s therascreen FGFR RGQ RT-PCR kit was first approved by the U.S. FDA on April 4, 2019. 

It is the only in vitro diagnostic reagent in Korea to guide the prescription of Balversa (ingredient: erdafitinib), a new FGFR kinase inhibitor developed by Janssen.

Urothelial cancer begins in tissues in the bladder and other urinary tracts but more than 90 percent are found in the bladder. Bladder cancer is the tenth most common cancer in the world, with a steadily increasing incidence rate worldwide. The FGFR regulates cell growth, metastasis, and survival, but leads to cancer if mutations occur. Certain gene mutations of FGFR, which play an important role in cancer cell growth, have been found in some urothelial cancers.

The therascreen FGFR kit is a qualitative target drug for diagnosing two-point mutations in Exon 7 in the FGFR3 gene, two-point mutations in Exon 10 and two fusions in the FGFR3 gene by real-time RT-PCR using RNA samples derived from formalin-fixed paraffin-embedded (FFPE) tumor tissue in urothelial carcinoma patients.

"With the approval of the therascreen FGFR kit, patients with urothelial cancer can more accurately and safely test for the FGFR 3 gene and receive more appropriate and effective treatment according to their specific genetic mutations," Qiagen Korea CEO William Lin said.

 

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