EGFR 29 Mutations Detection Kit
PCR
Ensayos de PCR en tiempo real
29
Mutations
10
Compatible Instrument
100%
100%
Specificity
100%
100%
Accuracy
1%
1%
Sensitivity
Features
Selectable
- Pre-loaded and bulk formats are available.
1
- Pre-loaded and bulk formats are available.
Universal
- Compatible with tissue, peripheral blood samples.
2
- Compatible with tissue, peripheral blood samples.
Precise
- Top sensitivity of 1% mutant allele.
3
- Top sensitivity of 1% mutant allele.
Easy
- One-step procedure, results in 90 mins.
4
- One-step procedure, results in 90 mins.
Reliable
- Internal and external controls included.
5
- 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:

•T790M

• 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
Rotor-Gene 6000
Rotor-Gene Q
SLAN-96S
Stratagene Mx3000P™
Other Info.

To order, please contact sales@amoydx.com.

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
8.01.20201W010B
8.01.20201W010C

8.01.20201W010D

 EGFR 29 Mutations Detection Kit (Bulk)

 24T

-20℃

8.01.20201X024E
8.01.20201X024F
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