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Human B-raf Gene Mutation Detection Kit

Human B-raf Gene Mutation Detection Kit

Real Time PCR

CE-IVD Certificate no.:No.MDD-SZ-XW-160321


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 and so on.


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 drug ineffectiveness. Mutations of BRAF occurred  in many cancers such as malignant melanoma, colorectal cancer, lung cancer, thyroid cancer, liver cancer, pancreatic cancer and so on.


Clinical Practice Guideline for colorectal cancer (NCCN) (2016 V2 Edition) suggested that the status of KRAS should be detected while using the targeted drugs such as Cetuximab and Panitumumab. If there is no mutation in KRAS, a further detection of BRAF gene status should be considered.


B-raf Gene Mutation &Drugs




Detection Item

GeneGene StatusDrug Indications
V600

patients with

KRAS mutation

Gefitin(Iressa)

Erlotinib(Tarceva)

Icotinib( Conmana)

Afatinib ( Gilotrif)

Osetini(AZD9291,Osimertinib)

Cetuximab (Erbitux)

Panitumumab(Vectibix)

Nimotuzumab (Nimotuzomab)

resistant


Schunitinib

Vemurafenib (Zelboraf), 

Darafini

sensitive
Imatinib


Performance Parameter

Product NameTechnology

Product

Specification

Matched

Instrument

Sample Type

Human B-raf

Gene Mutation

Detection Kit

PAP-ARMS?20 tests/kit

tratagene Mx3000P?,

ABI7500...

tumor tissue


Detection Significance

● Detection of B-raf gene status can help monitor the drug efficacy/resistance, thus, avoid unnecessary treatments and save treatment cost of the patients.

 Patients with B-raf gene mutation will be resistant to Gifetini, Osetini, cetuximab treatments, therefore, a detection of gene status before taking drugs will assist the clinicians to select suitable targeted drugs and minimize the waste of medical resources.

 Guide the selection of suitable targeted drugs for patients with B-raf mutation.


Applicable People

 A detection of B-raf gene status can be used to select targeted drugs (such as Rofetini) for patients with

some kinds of tumor (such as melanoma) before starting the targeted treatments.

A detection of B-raf gene status can be used to predict drug resistance before taking EGFR-TKI drugs.



Technical Highlights


Accuracy and Reliability: Detection with closed tubes. Require no special treatment of the products.

High Sensitivity: Accurate detection of single copies of mutated DNA samples as little as10ng genome.

Easy operation: One-step operation. 90 minutes of the whole process.

Good Reproducibility: Can be performed in the general PCR Labs. Results with good reproducibility can be easily obtained without special training.

Advanced Technology: R&D based on independent patented PAP-ARMS technology.



Detection Process













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