

Fluorescence PCR · Oncology
KRAS 8 Mutations Detection Kit (Fluorescence PCR)
Qualitative in vitro detection of eight mutations in codons 12 and 13 of the KRAS gene from DNA extracted from human paraffin-embedded pathological sections. For oncology applications.
- SKU Code
AENE-TM014- Approval
- On request
- Product Type
- Assay / Kit
- Status
- Available
Qualitative in vitro detection of eight mutations in codons 12 and 13 of the KRAS gene from DNA extracted from human paraffin-embedded pathological sections. For oncology applications.
| Product type | Assay / Kit |
|---|---|
| Technology platform | Fluorescence PCR |
| Application area | Oncology |
Certificate
CE/TFDA/Myanmar FDA
Epidemiology
KRAS point mutations are prevalent across various human cancers, with an overall tumor mutation rate of approximately 17–25%, 15–30% in lung cancer, and 20–50% in colorectal cancer. The K-ras gene encodes the P21 protein, which functions downstream of the EGFR signaling cascade. When K-ras is mutated, the downstream pathway becomes constitutively active, bypassing inhibition by EGFR-targeted drugs, leading to uncontrolled cell proliferation. These mutations typically confer resistance to EGFR tyrosine kinase inhibitors in lung cancer and to anti-EGFR antibody therapies in colorectal cancer. In 2008, the National Comprehensive Cancer Network (NCCN) published colorectal cancer guidelines noting that activating K-ras mutations predominantly occur in codons 12 and 13 of exon 2, and recommending K-ras mutation testing for all patients with advanced metastatic colorectal cancer prior to treatment. Thus, rapid, accurate detection is crucial for guiding therapy. This assay utilizes DNA samples for qualitative mutation status evaluation, aiding clinicians in identifying colorectal cancer, lung cancer, and other tumor patients likely to benefit from targeted therapies. The results are for clinical reference only; they should not be the sole basis for individualized treatment decisions. Clinicians must interpret findings in conjunction with the patient’s overall condition, drug indications, treatment response, and other laboratory parameters.
Work Flow
It is recommended to use a commercial DNA FFPE tissue kit and a paraffin-embedded tissue DNA rapid extraction kit.
| SKU code | AENE-TM014 |
|---|---|
| Storage | Liquid: ≤-18℃ In dark; Lyophilized: ≤30℃ In dark |
| Shelf-life | Liquid: 9 months; Lyophilized: 12 months |
| Specimen Type | paraffin-embedded pathological tissue or section contains tumorous cells |
| CV | ≤5.0% |
| LoD | K-ras Reaction Buffer A and K-ras Reaction Buffer B can stably detect 1% mutation rate under 3ng/μL wild-type background |
| Applicable Instruments | Applied Biosystems 7500 Real-Time PCR Systems Applied Biosystems 7300 Real-Time PCR Systems QuantStudio®5 Real-Time PCR Systems LightCycler® 480 Real-Time PCR system BioRad CFX96 Real-Time PCR System |
| Approval | On request |
|---|---|
| Documents | Datasheet, IFU, SDS, COA / conformance, origin, and export documents where available |
FAQ
What should be confirmed before quotation?
Sample context, collection method, and extraction workflow should be confirmed before final kit selection.
Which documents can be requested?
Datasheet, IFU, SDS, COA / conformance, origin, insurance, and export documents can be checked where available.
Can the format be adjusted for different workflows?
Liquid or lyophilized format options should be confirmed together with instrument compatibility and shipment requirements.
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