Products
The therascreen BRAF V600E RGQ PCR Kit is intended for in vitro diagnostic use.
QIAamp DNA FFPE Tissue Kit (50)
Cat. No. / ID: 56404
For 50 DNA preps: 50 QIAamp MinElute Columns, Proteinase K, Buffers, Collection Tubes (2 ml)
Use our next-generation QIAamp DNA FFPE Advanced Kits for improved performance.
Rotor-Gene AssayManager v2.1
Cat. No. / ID: 9024203
Software for routine testing in combination with Rotor-Gene Q and Rotor-Gene Q MDx instruments. IMPORTANT: Does not include license for use. License key must be purchased separately. Visit the Download Page for download, installation and licensing instructions.
For up-to-date licensing information or Rotor-Gene Q instrument specific disclaimers, refer to the corresponding Rotor-Gene Q instrument user manual
Rotor-Gene AssayManager v2.1 License (1)
Cat. No. / ID: 9025620
Single license for the installation of Rotor-Gene AssayManager v2.1 software on one computer. For installation on multiple computers, each computer requires an individual computer-specific license key.Visit the Download Page for software download, installation and licensing instructions.
Features
- PMDA-approved BRAF mutation companion diagnostic test
- Reliable detection of V600E mutations in the BRAF gene
- High sensitivity and specificity
- Simple workflow from sample to insight
- Automated data analysis using Rotor-Gene AssayManager for fast, easy result determination
Product Details
The therascreen BRAF V600E RGQ PCR Kit is a qualitative in vitro diagnostic test for the detection of V600E mutations in the BRAF gene. The test analyzes DNA extracted from formalin-fixed, paraffin-embedded (FFPE) tumor tissue, taken from a patient with colorectal cancer (CRC). It is intended to aid clinicians in identifying metastatic colorectal cancer (mCRC) patients eligible for treatment with either a triplet therapeutic regime of BRAFTOVI (encorafenib) plus MEKTOVI (binimetinib) plus cetuximab (genetic recombinant), or a doublet therapeutic regime of BRAFTOVI (encorafenib) plus cetuximab (genetic recombinant).
Performance
The clinical performance of the kit was determined in the BEACON CRC Study. This was a three-arm, multicenter, randomized, open-label, Phase 3 study of encorafenib + cetuximab (genetic recombinant) plus (triplet arm) or minus (doublet arm) binimetinib versus irinotecan/cetuximab (genetic recombinant) or infusional 5-fluorouracil/folinic acid/irinotecan/cetuximab (genetic recombinant) (control arm) in patients with BRAF V600E mutant metastatic CRC.
The study comprised 665 patients (224 triplet arm; 220 doublet arm; 221 control arm). Study endpoints included overall survival (OS) and overall response rate (ORR) by BICR (Blinded Independent Central Review) per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).
The study demonstrated a statistically significant clinical improvement in OS and confirmed ORR by BICR for both the triplet and the doublet arm versus the control arm, with a 48% (triplet) and 40% (doublet) reduction in risk of death observed compared to the control arm (triplet: HR 0.52, 95% CI: 0.39, 0.70; doublet: HR 0.60, 95% CI: 0.45, 0.79).
Therefore, there is a clear clinical benefit to determining BRAF mutation status when determining patient eligibility for treatment with either encorafenib + cetuximab (genetic recombinant) + binimetinib or encorafenib + cetuximab (genetic recombinant).
Principle
The therascreen BRAF V600E RGQ PCR Kit is comprised of one mutation and one control reaction mix utilized to detect the V600E mutation in the BRAF gene. Allele-specific technology allows accurate and highly reproducible detection of mutations; DNA is selectively amplified using ARMS primers and Scorpions probes, with sensitive signal detection using the Rotor-Gene Q MDx instrument. Result reporting is fully automated. If both the run controls and the sample results are valid and target assay amplification is below the preset cutoff, the report will show the V600E mutation as detected in the sample.
Procedure
The simple and easy testing workflow begins with manual DNA extraction from mCRC tumor tissue using the QIAamp DNA FFPE Tissue Kit, followed by sensitive real-time PCR on the Rotor-Gene Q MDx instrument. Rotor-Gene AssayManager software rapidly and accurately determines mutations and reports results, informing the system operator if the V600E mutation is present in the sample.
Applications
The therascreen BRAF V600E RGQ PCR Kit enables qualitative detection of V600E mutations in the BRAF gene for in vitro diagnostic use. It is an PMDA-approved companion diagnostic assay to identify patients with cases of metastatic colorectal cancer for whom treatment with BRAFTOVI (encorafenib) plus MEKTOVI (binimetinib) plus cetuximab (genetic recombinant), or BRAFTOVI (encorafenib) plus cetuximab (genetic recombinant) may be appropriate.
Resources
Brochures & Guides (6)
Kit Handbooks (5)
Operating Software (1)
Safety Data Sheets (3)
Protocol Files (1)
Additional Resources (1)
Supplementary Protocols (1)
Certificates of Analysis (1)
FAQ
I received a kit containing the MinElute columns; however, they were left out for a while and not stored at 2–8°C upon receipt. Can I still use them?
What is the composition of elution buffer ATE in the QIAamp DNA Investigator kit, QIAamp DNA FFPE Tissue kit and the QIAamp Fast DNA Stool Mini kit?
What can be used as an alternative to the A260 measurement for quantification of small amounts of RNA and DNA?