THXID^®-BRAF

THXID-BRAF OVERVIEW

The THXID-BRAF kit: The first FDA-approved IVD for BRAF V600E and V600K mutation detection in metastic melanoma.

The THXID-BRAF kit is an In Vitro Diagnostic device intended for the qualitative detection of the BRAF V600E and V600K mutations in DNA samples extracted from formalin-fixed paraffin-embedded (FFPE) human melanoma tissue. The THXID-BRAF kit is a real-time PCR test on the ABI 7500 Fast Dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist^®].

Package Inserts

Tafinlar and Mekinist are registered trademarks of Novartis Pharmaceuticals Corporation.

THXID-BRAF PROVIDING LABORATORIES

The THXID-BRAF kit: The first FDA-approved IVD for BRAF V600E and V600K mutation detection in metastic melanoma.

Reference laboratories offering the The THXID-BRAF test:

THXID-BRAF INFORMATION FOR TEST CENTERS

The THXID-BRAF kit: The first FDA-approved IVD for BRAF V600E and V600K mutation detection in metastic melanoma

About the THXID-BRAF Kit
The THXID-BRAF kit allows detection of the V600E and V600K mutations of the BRAF gene from FFPE sections. The kit makes use of two major processes:

• THXID-BRAF PUR:
  Nucleic acid isolation from FFPE sections through extraction / purification steps.
• THXID-BRAF AMP:
  Real time PCR amplification and detection of target DNA (BRAF gene) present in the total nucleic acids: Amplification Refractory Mutation Specific System (ARMS) PCR technology is used. In the THXID-BRAF kit, 2 different probes labeled with 2 different dyes allow the simultaneous detection of the BRAF internal control and a BRAF mutation. Kinetic analysis of the fluorescent signals and delta Ct (Crossing threshold) calculation reveal the presence of potential BRAF mutations. Two separate amplification wells or tubes are used for each clinical sample or control.

The kit contains sufficient reagents and materials for 48 reactions. A minimum of one positive control and one negative control reaction is consumed per batch of clinical samples. The kit therefore allows processing of up to 46 clinical samples at the maximum batch size of 46 clinical samples per run. Smaller runs sizes will be decrease the number of clinical results that can be obtained from a 48-reaction kit.

THXID-BRAF Software:
The THXID BRAF Software gives an interpretation of data obtained from the ABI 7500 Fast Dx Real-Time PCR instrument and SDS software version 1.4. The THXID BRAF Software imports raw data from the specified SDS file, checks the validity of the run and automatically interprets the results of the SDS file created by the SDS Software by indicating whether the mutation has been detected or not for each clinical sample. The THXID BRAF Software is provided with the purchase of the first ThXID BRAF kit by a bioMérieux Field Application Specialist.

Ordering Information:

By Phone: Please contact bioMérieux, Inc. at 800-682-2666.

By Web: Submit a request for information here.