therascreen BRAF V600E RGQ PCR Kit

For qualitative detection of V600E mutations in the BRAF gene using real-time PCR

Features

  • FDA-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

Products

The therascreen BRAF V600E RGQ PCR Kit is intended for in vitro diagnostic use.
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therascreen BRAF V600E RGQ PCR Kit (24)

Cat. No. / ID: 874821

For 24 reactions: Control Reaction Mix, V600E Reaction Mix, BRAF Positive Control, Taq DNA Polymerase, Water for NTC, Water for Dilution
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QIAamp DSP DNA FFPE Tissue Kit (50)

Cat. No. / ID: 60404

For 50 DNA preps: QIAamp MinElute columns, Proteinase K, Buffers, and Collection Tubes (2 ml)
$278.00
Add to cart
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Rotor-Gene Q MDx System (US)

Cat. No. / ID: 9002036

Real-time PCR cycler with 6 channels (the red and HRM channels are not intended for use with FDA cleared or approved nucleic acid tests), laptop computer, software, accessories, 1-year warranty on parts and labor, installation and training
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Rotor-Gene Q MDx Platform (US)

Cat. No. / ID: 9002035

Real-time PCR cycler with 6 channels (the red and HRM channels are not intended for use with FDA cleared or approved nucleic acid tests), laptop computer, software, accessories, 1-year warranty on parts and labor
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Rotor-Gene AssayManager v2.1

Cat. No. / ID: 9024203-US

Software for routine testing in combination with 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.
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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.

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 BRAFTOVI (encorafenib) in combination with cetuximab.

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 plus (triplet arm) or minus (doublet arm) binimetinib versus irinotecan/cetuximab or infusional 5-fluorouracil/folinic acid/irinotecan/cetuximab (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 the doublet arm versus the control arm, with a 40% reduction in risk of death observed with the doublet arm compared to the control arm (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 encorafenib + cetuximab.

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 (US) 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 DSP DNA FFPE Tissue Kit, followed by sensitive real-time PCR on the Rotor-Gene Q MDx (US) 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 FDA-approved CDx assay to identify patients with cases of metastatic colorectal cancer for whom treatment with BRAFTOVI (encorafenib) in combination with cetuximab may be appropriate.

Resources

Brochures & Guides (1)
High-quality, nucleic acid purification for successful PCR and NGS experiments.
Kit Handbooks (2)
For in vitro diagnostic use

Rx only (For prescription use only)

For use with QIAamp DSP DNA FFPE Tissue Kit

For use with Rotor-Gene Q MDx (US) instruments
Instrument User Manuals (2)
For use with Rotor-Gene Q Software version 2.3.4
For use with Rotor-Gene Q Software version 2.3.4
Protocol Files (1)
BRAF US RGAM assay profile

FAQ

What can be used as an alternative to the A260 measurement for quantification of small amounts of RNA and DNA?

Small amounts of RNA and DNA may be difficult to measure spectrophotometrically. Fluorometric measurements, or quantitative RT-PCR and PCR are more sensitive and accurate methods to quantify low amounts of RNA or DNA.

Fluorometric measurements are carried out using nucleic acid binding dyes, such as RiboGreen® RNA Quantitation Reagent for RNA, and PicoGreen® DNA Quantitation Reagent for DNA (Molecular Probes, Inc.).

FAQ ID -728