AmoyDx - Multi-Gene Mutations Detection Kit
From Real-time PCR Assays
Lung cancer is one of the most common malignant tumor, and 80~85% of lung cancers are non-small cell lung cancer (NSCLC). There are many driver mutations in NSCLC. The frequency of mutations in patients with NSCLC for the EGFR gene is 10~35%, for KRAS 15?25%, for BRAF1-4%, for NRAS is 1%, for HER2 2-4%, and for PIK3CA 1-3%. About 3-7% of NSCLC patients have gene fusion in ALK, 2% in ROS1, and 1% in RET. A large amount of clinical studies showed that gene mutation status is important efficacy predictor for targeted therapy.
Details
For instance, EGFR-TK1 would show better efficacy on patient with EGFR sensitizing mutation than the patient with wild-type gene, the presence of the ALK, ROS1 and RET gene fusions are correlated with the efficacy of TKI therapy, and KRAS, BRAF, NRAS, HER2 and PIK3CA are associated with prognosis of some targeted drugs It is indicated in NCCN Guideline for NSCLC that gene mutation testing is required before targeted therapy, and it is strongly recommended to conduct multi-target test to determine the optimal precision oncology treatment.
Intended Use
The AmoyDx® Multi-Gene Mutations Detection Kit is a real-time PCR assay for qualitative detection of 118 hotspot mutations/fusions in EGFR, KRAS, BRAF, NRAS, HER2, PIK3CA, ALK, ROS1 and RET genes in human genomic DNA and total RNA extracted from formalin-fixed paraffin-embedded (FFPE) tumor tissue. The kit is intended to be used to aid clinician to identify the multi-target status of NSCLC patients.
The kit is for research use only, and intended to be used by trained professionals in a laboratory environment.
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