Fluorescence PCR · Oncology
EML4-ALK Fusion Gene (12 Mutations) Detection Kit (Fluorescence PCR)
Qualitative detection of 12 EML4-ALK fusion gene mutation types in samples from non-small cell lung cancer patients. For clinical reference, aiding in patient management decisions alongside other clinical and laboratory findings.
- SKU Code
AENE-TM006- Approval
- On request
- Product Type
- Assay / Kit
- Status
- Available
Qualitative detection of 12 EML4-ALK fusion gene mutation types in samples from non-small cell lung cancer patients. For clinical reference, aiding in patient management decisions alongside other clinical and laboratory findings.
| Product type | Assay / Kit |
|---|---|
| Technology platform | Fluorescence PCR |
| Application area | Oncology |
Certificate
TFDA
Epidemiology
The assay qualitatively detects 12 different EML4-ALK fusion variants in specimens from individuals with non-small cell lung cancer (NSCLC), for in vitro use. Results serve as clinical reference and must not be the sole determinant of personalized therapy; clinicians should integrate findings with patient status, drug indications, treatment responses, and other laboratory parameters. Lung cancer is the leading malignancy globally, with NSCLC representing 80–85% of cases. The fusion between echinoderm microtubule-associated protein-like 4 (EML4) and anaplastic lymphoma kinase (ALK) is a key therapeutic target in NSCLC. These genes reside on chromosome 2 at bands 2p21 and 2p23, separated by roughly 12.7 Mb. Over 20 fusion variants exist; Table 1 lists 12 commonly encountered mutations. Variant 1 (E13;A20) predominates (~33% of EML4-ALK-positive NSCLC), followed by variants 3a and 3b (E6;A20), together accounting for about 29%. Small-molecule ALK inhibitors such as crizotinib are designed to block ALK tyrosine kinase activity and downstream signaling, suppressing tumor growth. Clinical trials demonstrate a response rate exceeding 61% in fusion-positive patients, while wild-type patients remain largely unresponsive. Hence, detecting EML4-ALK fusions is essential for selecting patients for crizotinib therapy.
Work Flow
Recommended extraction reagents: a commercial FFPE RNA extraction kit and a total RNA extraction kit tailored for paraffin-embedded tissue sections (e.g., catalog number DP439).
| SKU code | AENE-TM006 |
|---|---|
| Storage | ≤-18℃ |
| Shelf-life | 9 months |
| Specimen Type | paraffin-embedded pathological tissue or section samples |
| CV | ＜5.0% |
| Ct | ≤38 |
| LoD | This kit can detect fusion mutations as low as 20 copies. |
| Applicable Instruments | : Applied Biosystems 7500 Real-Time PCR Systems Applied Biosystems 7500 Fast Real-Time PCR Systems SLAN ®-96P Real-Time PCR Systems QuantStudio™ 5 Real-Time PCR Systems LightCycler®480 Real-Time PCR system LineGene 9600 Plus Real-Time PCR Detection System MA-6000 Real-Time Quantitative Thermal Cycler BioRad CFX96 Real-Time PCR System BioRad CFX Opus 96 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.
Inquiry
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