Amoy Diagnostics Co.,Ltd.

The AmoyDx EGFR Mutation Test Kit is a sensitive and selective assay for the detection of the most informative somatic mutations in the epidermal growth factor receptor (EGFR) gene. It is used clinically in China to select NSCLC patients who are most likely to respond to Iressa (Gefitinib) or Tarceva (Erlotinib). AmoyDx works closely with AstraZeneca in China to promote the use of molecular diagnostic tests for patient stratification.


The EGFR assay tests for a total of 29 mutations in eight PCR tubes, including both activating and resistance mutations. The presence of activating mutations indicates predicted response to mutant EGFR-targeting drugs. If the tumor tissue harbors resistance mutations, it may respond poorly to therapies designed to inhibit EGFR signalling.


The American Society for Clinical Oncology (ASCO) recommends that patients with NSCLC who are being considered for first-line therapy with an EGFR TKI (patients who have not previously received chemotherapy or an EGFR TKI) should have their tumor tested for EGFR mutations to determine whether an EGFR TKI or chemotherapy is the appropriate first-line therapy. (Keedy, V.L. et al. (2011) J. Clin. Oncol. 29(15), 2121).

 
The European Committee for Medicinal Products for Human Use (CHMP) recommended that EGFR mutation status be tested in patients with metastatic non-small cell lung cancer to predict sensitivity to Iressa. (EPAR summary for the public. EMEA/280173/2009. EMEA/H/C/1016).


Intended Use: 
CFDA approved for clinical use in China and CE marked for IVD use in Europe. 
 
Technological Principles:
The EGFR kit employs proprietary real-time PCR technology to detect 29 mutations in the EGFR gene. Target DNA is amplified with mutation-specific PCR primers, and the mutant amplicons are detected with a novel fluorescent probe. For high quality DNA, about 2 ng of purified DNA is added to each PCR tube. For DNA from FFPE tissue older than three years, 10 to 15 ng of DNA is recommended. The test can detect mutations at a sensitivity of 1% ( i.e., one mutant copy to 99 wild-type copies). 
 
The EGFR mutation kit enables detection of the following mutations:

 
•T790M
• L858R
• L861Q
• S768I
• G719S，G719A and G719C
• 3 insertions in exon 20 (detects the presence of any of 3 insertions but does not distinguish between them)
• 19 deletions in exon 19 (detects the presence of any of the 19 deletions but does not distinguish between them).

AmoyDx EGFR 29 Mutations Detection Kits are available in the following size, minimum order of 12 tests:

 Key Features and Benefits:
• Simple Procedure — only one step required for sample application, results obtained within 90 minutes.
• High sensitivity and accuracy — can detect 1% mutant DNA in a background of wild type genomic DNA.
• ADx-ARMs technology — employs a patented two-step PCR amplification procedure and novel fluorescent probe design.
• Easy Standardization — any general PCR lab can perform the test, and technicians obtain reproducible results without specialized training.
• Reliable product quality — Produced in a dedicated GMP plant, with quality management systems that have passed Chinese CFDA and international ISO13485 standards.
• Sample type: Fresh, frozen or paraffin embedded tissue; blood, serum or plasma.