EGFR 29 Mutations Detection Kit
Real-time PCR Assays
Compatible Instrument
- Pre-loaded and bulk formats are available.
- Pre-loaded and bulk formats are available.
- Compatible with tissue, peripheral blood samples.
- Compatible with tissue, peripheral blood samples.
- Top sensitivity of 1% mutant allele.
- Top sensitivity of 1% mutant allele.
- One-step procedure, results in 90 mins.
- One-step procedure, results in 90 mins.
- Internal and external controls included.
- Internal and external controls included.
Product Description

EGFR 29 Mutations Detection Kit

The AmoyDx EGFR Mutations Detection 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).

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:


• L858R

• L861Q

• S768I

• G719SG719A 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).

Testing Procedure
Compatible Sample Types:FFPE tissue or plasma/serum samples
Compatible Real-time PCR Instrument
ABI 7300
ABI 7500
ABI 7900 HT
ABI StepOnePlus
Bio-Rad CFX96
LightCycler 480 II
Rotor-Gene 6000
Rotor-Gene Q
Stratagene Mx3000P™
Other Info.

To order, please contact
AmoyDx EGFR 29 Mutations Detection Kits are available in the following size, minimum order of 10 tests:

 Product Name Tests/Kit  Storage Cat. No.
EGFR 29 Mutations Detection Kit (Pre-loaded) 10T -20℃ 8.01.20201W010A

 EGFR 29 Mutations Detection Kit (Bulk)  24T -20℃ 8.01.20201X024E

1. Liu, Xiaoqing, et al. "The diagnostic accuracy of pleural effusion and plasma samples versus tumour tissue for detection of EGFR mutation in patients with advanced non-small cell lung cancer: comparison of methodologies." Journal of clinical pathology 66.12 (2013): 1065-1069.
2. Yang, Haihong, et al. "Sensitive detection of EGFR mutations in cerebrospinal fluid from lung adenocarcinoma patients with brain metastases." The Journal of Molecular Diagnostics 16.5 (2014): 558-563.
3. Liu, Jinguo, et al. "ARMS for EGFR mutation analysis of cytologic and corresponding lung adenocarcinoma histologic specimens." Journal of cancer research and clinical oncology 141.2 (2015): 221-227.
4. Zhou, Juan, et al. "Prevalence and clinical profile of EGFR mutation in non-small-cell lung carcinoma patients in Southwest China." Asian Pacific Journal of Cancer Prevention 17.3 (2016): 965-971.
5. Ma, MeiLi, et al. "Comparison of plasma and tissue samples in epidermal growth factor receptor mutation by ARMS in advanced non-small cell lung cancer." Gene 591.1 (2016): 58-64.
6. Walsh, Kathy, and William A. Wallace. "Molecular pathology in lung cancer: a guide to the techniques used in clinical practice." Histopathology 65.6 (2014): 731-741.
7. Improta, Giuseppina, et al. "Epidermal growth factor receptor exon 20 p. S768I mutation in non-small cell lung carcinoma: A case report combined with a review of the literature and investigation of clinical significance." Oncology letters 11.1 (2016): 393-398.
8. Han, Baohui, et al. "EGFR mutation prevalence in Asia-Pacific and Russian patients with advanced NSCLC of adenocarcinoma and non-adenocarcinoma histology: the IGNITE study." Lung Cancer 113 (2017): 37-44.
9. Garcia, Jessica, et al. "Evaluation of pre-analytical conditions and comparison of the performance of several digital PCR assays for the detection of major EGFR mutations in circulating DNA from non-small cell lung cancers: the CIRCAN_0 study." Oncotarget 8.50 (2017): 87980.
10. Douillard, Jean-Yves, et al. "Gefitinib treatment in EGFR mutated caucasian NSCLC: circulating-free tumor DNA as a surrogate for determination of EGFR status." Journal of Thoracic Oncology 9.9 (2014): 1345-1353.
11. Fassunke, Jana, et al. "EGFR T790M mutation testing of non-small cell lung cancer tissue and blood samples artificially spiked with circulating cell-free tumor DNA: results of a round robin trial." Virchows Archiv 471.4 (2017): 509-520.

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