TEST:

therascreen® FGFR RGQ RT-PCR Kit

The therascreen FGFR RGQ RT-PCR Kit is a real-time, reverse transcription PCR test for the qualitative detection of two point mutations in exon 7 [p.R248C (c.742C>T), p.S249C (c.746C>G)], two point mutations in exon 10 [p.G370C (c.1108G>T) and p.Y373C (c.1118A>G)] and two fusions (FGFR3:TACC3v1 and FGFR3:TACC3v3) in the fibroblast growth factor receptor 3 (FGFR3) gene in RNA samples derived from formalin-fixed paraffinembedded (FFPE) urothelial tumor tissue. The test is indicated for use as an aid in identifying patients with cases of urothelial cancer (UC) which harbor these alterations and are therefore eligible for treatment with BALVERSA™ (erdafitinib). It is based on the selective amplification of alterations in the FGFR3 gene using the Rotor-Gene Q MDx 5plex HRM instrument for sensitive and specific analysis. The assay exploits the qPCR oligonucleotide hydrolysis principle using TaqMan probes. The therascreen FGFR RGQ RT-PCR Kit is also designed to identify FGFR2 fusions FGFR2-BICC1 and FGFR2-CASP7 and FGFR3 fusion FGFR3-BAIAP2L1