Amoy Diagnostics Co.,Ltd.

Currently there are several EGFR-TKIs approved for NSCLC (Non-small Cell Lung Cancer) targeted therapy including first-generation TKIs (gefitinib and erlotinib), second-generation TKI (afatinib) and third-generation TKI (osimertinib). To select right patients for these therapies, it is essential to detect EGFR mutation status before the treatment decision.

NSCLC tissue testing has been applied to EGFR mutation detection for years. However, up to 25% of patients with advanced or metastatic NSCLC do not have an available or sufficient tumor tissue sample for this method of testing. More and more dynamic monitoring demand for EGFR mutation status appears. When tissue sample is not a reliable or realistic option, the ctDNA (circulating tumor DNA) obtained from blood sample can be used for the assessment of EGFR mutation status.

Supe-rARMS^® EGFR kit is a highly sensitive, real-time PCR-based test which is designed to identify ctDNA EGFR mutation in plasma samples for patients with advanced or metastatic NSCLC. The kit adopts innovative Super-ARMS^®technology which is upgraded from ADx-ARMS technology. Its optimized reaction system can rapidly and accurately detect low percentage of mutant ctDNA in a background of wild-type DNA.

Intended Use: 
CFDA approved for clinical use in China and CE marked for IVD use in Europe. 
 
Technological Principles: 
The Super-ARMS^® EGFR mutation kit enables detection of the following 42 EGFR mutations:

• Exon 18: G719C, G719A, G719S

• Exon 19: 29 deletions

• Exon 20: T790M, S768I, 6 insertions

• Exon 21: L858R, L861Q

Customer Service Hotline: 86-592-6806835
Email：Sales@amoydx.com

Super-ARMS^® EGFR Mutation Detection Kit is available in the following size:

 Key Features and Benefits:

• Specific - Specific designed for multiple EGFR mutations testing 

• Universal - Compatible with peripheral blood, body fluid, FNA samples
• Precise - Top sensitivity of 0.2% mutant allele
• Extensive - Covers 42 most frequent EGFR mutations
• Rapid - One-step procedure, results in 120 minutes