Approval for the therascreen® fgfr rgq 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 paraffin-embedded (ffpe) urothelial tumor tissue. The test is indicated for use as an aid in identifying urothelial cancer (uc) patients who harbor these alterations and are therefore eligible for treatment with balversa™ (erdafitinib). Specimens are processed using the rneasy dsp ffpe kit for manual sample preparation followed by reverse transcription and then automated amplification and detection on the rotor-gene q mdx (us) instrument.
| Device | therascreen FGFR RGQ RT-PCR Kit |
| Generic Name | Dry Powder Inhaler |
| Applicant | QIAGEN GmbH |
| Date Received | 2018-11-08 |
| Decision Date | 2019-04-12 |
| PMA | P180043 |
| Supplement | S |
| Advisory Committee | Molecular Genetics |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN GmbH qiagen Strasse 1 hilden |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P180043 | | Original Filing |
| S003 |
2021-09-20 |
Real-time Process |
| S002 |
2020-03-04 |
30-day Notice |
| S001 | | |
NIH GUDID Devices