The AmoyDx KRAS Seven Mutations Detection Kit is a sensitive and selective assay for the detection of the most common somatic mutations in the KRAS gene. The KRAS gene mutation status of colorectal cancer patients is relevant to drug resistance of targeted medicines such as TKIS. The presence of mutant KRAS also predicts poor response to TKIs in non small cell lung cancer. Patients with wild-type KRAS gene are much more likely to benefit from the Erbitux (Cetuximab) or Vectibix (Panitumumab), compared to patients with a mutant KRAS gene. The European Drug Administration Organization and US FDA recommended the employment of KRAS gene mutation test prior to the usage of targeted medicine Erbitux and and Vectibix in the treatment of colorectal cancer.Reference:De Roock, Y., et al. Lancet Oncol 2011; 12: 594-603
Assay Highlights:1. One-step procedure2. Results in 90 minutes3. Detects 1% mutant allele4. Positive and negative controls5. External and internal controls6. CE marked for IVD use in Europe7. SFDA approved for clinical use in China8. ISO13485-certified laboratoryApplicable PCR instruments:1. ABI7300/7500/7900/StepOne2. Stratagene Mx 3000P/3005P3. LightCycler 480 I and II4. Bio-Rad CFX965. Qiagen RotorGene 6000/QMutations Detected in KRAS 7 Kit: 1. Gly12Asp 2. Gly12Ala 3. Gly12Val 4. Gly12Ser5. Gly12Arg6. Gly12Cys7. Gly13AspSample type: fresh, frozen, paraffin embedded tissue, blood, and serum specimens
Product Specification / Models
ADx-KR01: pre-loaded, 12tests/kit;ADx-KR02: in bulk, 24tests/kit;Note: 1. "Pre-loaded" kits have the buffer, primers, probes, and nucleotides pre-loaded into the PCR strips. The user just adds the sample DNA and Taq enzyme (included in the kit). 2. Bulk means the user pipettes the reagents into the PCR tubes.
Application / Models
Sample type: fresh, frozen, paraffin embedded tissue, blood, and serum specimens
CE marked for IVD use in Europe; SFDA approved for clinical use in China; ISO13485 certified;
Amoy Diagnostics provides state-of-the-art molecular diagnostic products and services to healthcare providers, academic institutions, and pharmaceutical companies. The company has a rich portfolio of tests that focuses on detecting mutations and measuring gene expression in FFPE cancer tissue.
The assays are based on a proprietary real-time PCR technology called “ADx-ARMS”. They have outstanding sensitivity (1%) and accuracy (99%). EGFR, KRAS, BRAF, PIK3CA and EML4-ALK tests have received both CE declarations for marketing in Europe and SFDA approval for clinical use in China, ROS1 and ERCC1 assays are CE marked for IVD use in Europe.
The assays are designed and tested in an ISO-13485 certified laboratory and assembled in a dedicated GMP-compliant manufacturing plant. In addition to the EGFR, KRAS and BRAF tests, the company has kits for detecting mutations in JAK2, KIT, BCR-ABL, PIK3CA, EML4-ALK, P53 and the RET oncogene. Quantitative gene expression assays for excision repair (ERCC1), thymidine phosphorylase (TYMP), stathmin (STMN1), ribonucleotide reductase (RRM1) and other genes provide valuable information to help predict chemotherapy responses.
The assays are easy to perform, provide results in 90 minutes, and have been validated on several PCR instruments that are commonly used in diagnostic laboratories.
AmoyDx supplies EGFR tests to AstraZeneca in China. Amoy Diagnostics and AstraZeneca work closely together to foster the growth of molecular diagnostic testing for lung cancer patients in mainland China.
AmoyDx also supplies ROS1 tests for pivotal clinical trial of Pfizer's crizotinib in China, Korea, and Japan.
Located in beautiful Xiamen, China, Amoy Diagnostics is a privately held, well-financed company with a rich and growing pipeline of molecular diagnostic products. Our mission is to be a leading global supplier of high quality diagnostic products.
We will accomplish this mission by:
1. Adhering to the strictest manufacturing standards to provide quality products at competitive prices.
2. Maintaining an unsurpassed level of customer service and satisfaction.
3. Pursuing scientific innovation as we provide our customers with practical leading-edge technologies
and value-added products.
4. Creating a world-class organization that contributes positively to the lives of our employees, our customers, and the scientific community.
Note: The EGFR, KRAS, BRAF, PIK3CA and EML4-ALK and ROS1 tests are approved for clinical use in China and are CE marked for IVD use in Europe. ROS1 and ERCC1 assays are CE marked for IVD use in Europe. Any other use of the assays is for research purposes only.