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Human EGFR Gene Mutations Detection Kit

Human EGFR Gene Mutations Detection Kit

Real Time PCR

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



Individualized targeted therapy: Using new methods of molecular analysis, to help doctors andpatients choose the most effective drugs, and to better control the disease progression according to the patient's genetic characteristics, thus to develop a suitable individualized therapy.



EGFR-TKI Drugs and EGFR Gene



EGFR is a transmembrane receptor tyrosine kinase, which could be activated by anti-phosphorylationupon ligand binding, the activation of EGFR contributes to cancer cell proliferation and relevant signal transductin significantly.The status of EGFR gene mutation is the most important factor forpredicting EGFR-TKI efficacy, which is the prerequisite for determining whether the EGFR-TKI therapy is suitabel for the specific patients.


NCCN clinical practice guidelines in oncology,Non-Small Cell Lung Cancer (Version 4.2016) recommends that pathological assessment of patients with advanced lung adenocarcinoma requires detection of mutations in EGFR, KRAS and ALK genes to guide TKI drug therapy. The College of American Pathologists (CAP), the International Association for the Study of Lung Cancer (IASLC), and the Association for Molecular Pathology (AMP) have released Guideline of Lung Cancer Biomarker detection 2013, which clearly pointed out that all patients with advanced lung adenocarcinoma should be detected for the mutation status of EGFR and ALK genes, thus to be the judgment basis to determine whether specific tyrosine kinase inhibitors treatment can be applied to patients.


Detection Items

Product

Product

Specification

Matched

Instrument

Detecting

Items
Sample Requirements
Sample TypeQuantity

Preservation

Condition

Human EGFR

Gene Mutations

Detection Kit

10tests

/kit

Stratagene

Mx3000pTM/

3005pTM

ABI7500/

7300

Detect 29

mutational

sites related

to drug

resistance of

EGFR.

peripheral

blood

10mL2~6℃
FFPE tissue

7 sections

5-10 μm

room

temperature

pleural effusion50-500mL-20℃±5℃



Detection Process





Advantages and Characteristics



Accuracy and ReliabilityDetection with closed tubes. Require no special treatment of the products.

High SensitivityAccurate detection of single copies of mutated DNA samples as little as10ng genome.

Easy operationOne-step operation. 90 minutes of the whole process.

Good ReproducibilityCan 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.