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B-raf Gene Mutation Detection Kit


CE-IVD


BRAF gene plays an important role in signal transduction involving cell proliferation, by regulating various kinds of cell physiological activities, such as growth, division , death etc.

BRAF gene is the second transmitter in the EGFR signaling pathway. When BRAF gene mutations occurs, the signal pathway will be permanently auto-activated, resulting in excessive cell proliferation and differentiation, thus, which may lead to EGFR-TKI  ineffectiveness. Mutations of BRAF occurred in many cancers such as malignant melanoma, colorectal cancer, lung cancer, thyroid carcinoma, liver cancer,etc.

The NCCN Guidelines for Colorectal Cancer (2023 Edition) recommends that all patients with metastatic colorectal cancer can be genotyped for B-raf and K-ras mutations.




B-raf Gene Mutation &MEDICINE 

Some of the targeted drugs are designed to directly target the B-raf mutation to provide treatment options.


DETECTED GENES


GeneCancer TypeGene StatusTarget DrugDrug Indications
B-raf V600ENSCLCMutation type

Trametinib + Dabrafenib/

 Vemurafenib

Sensitive

CRCMutation typeEncorafenib+ Cetuximab/ 

Panitumumab

Sensitive
Wild typeCetuximab/ PanitumumabSensitive
MelanomaMutation type

 Vemurafenib+ Cobimetinib/

Binimetinib/ Trametinib + Dabrafenib

Sensitive

Solid Tumors

Mutation type

Trametinib + Dabrafeni

Sensitive




PRODUCT INFORMATION

Product Name

Core Technology

Pack SizeInstruments ValidatedSample Type

B-raf Gene Mutation

Detection Kit

PAP-ARMS®20 Tests/Kit

ABI7500, ABI7300, 

ABI StepOne Plus, 

LightCycler480, 

Bio-Rad CFX96, etc.

Tumor tissue,

Peripheral blood,

Pleural and ascites 


DETECTION SIGNIFICANCE

1、BRAF V600E mutation makes response to anti-EGFR or anti-HER2 therapies highly unlikely.

2Select patients for treatment with BRAF/MEK inhibitors based on the presence of BRAF V600E.

3When MLH1 expression is absent, the presence of BRAF V600E is consistent with sporadic cancer.

4Molecular diagnostics may be useful to reclassify follicular lesions. BRAF V600E suggests papillary thyroid carcinoma.




FEATURES & ADVANTAGES

1. Accuracy and Reliability:  Use pre-load PCR tube to effectively avoid cross-contamination.

2. High Sensitivity:  Sensitivity can detect V600E mutations as low as 1%in 10 ng DNA.

3. Ease of Use:  Based on technology PAP-ARMS®, one step detection in 90 mins. 

4. Great versatility:Validated on the most common qPCR machines with stable results.

 

 


DETECTION PROCESS 

1.Nucleic Acid Extraction

2.Set up qPCR

3.Amplification

4.Data Analysis