For qualitative detection of actionable alterations in the FGFR3 gene
The therascreen FGFR RGQ RT-PCR Kit is a qualitative in vitro diagnostic test for the 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 FGFR3 gene.
The therascreen FGFR RGQ RT-PCR Kit is the only FDA-approved companion diagnostic (CDx) test for the identification of patients with cases of urothelial cancer (UC) that harbor these actionable FGFR alterations, and for whom treatment with BALVERSA (erdafitinib) is indicated.