Approval for the therascreen braf v600e rgq pcr kit. The therascreen braf v600e rgq pcr kit is a real-time pcr test for the qualitative detection of v600e mutations in the braf gene using genomic dna extracted from formalin-fixed paraffin-embedded (ffpe) human colorectal cancer (crc) tumor tissue. The therascreen braf v600e rgq pcr kit is an in vitro diagnostic device intended to be used as an aid in selecting patients with metastatic colorectal cancer (mcrc) whose tumors carry the braf v600e mutation for treatment with braftovi (encorafenib) in combination with cetuximab. The therascreen braf v600e rgq pcr kit is for use on the rotor-gene q mdx (us) instrument. The therascreen braf v600e rgq pcr kit is intended for in vitro diagnostic use.
| Device | therascreen BRAF V600E RGQ PCR Kit |
| Generic Name | Somatic Gene Mutation Detection System |
| Applicant | QIAGEN GmbH |
| Date Received | 2019-09-30 |
| Decision Date | 2020-04-15 |
| PMA | P190026 |
| Supplement | S |
| Product Code | OWD |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | QIAGEN GmbH qiagen Strasse 1 hilden 40724 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190026 | Original Filing |