therascreen BRAF V600E RGQ PCR Kit

• 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

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).

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).

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.

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.

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.