Fluorescence PCR · Oncology
Human ROS1 Fusion Gene Mutation Detection Kit (Fluorescence PCR)
This fluorescence PCR kit qualitatively detects 14 ROS1 fusion gene mutations in human non-small cell lung cancer (NSCLC) specimens. Results are for clinical reference; not to be used as the sole basis for patient treatment decisions.
- SKU Code
AENE-TM009- Approval
- On request
- Product Type
- Assay / Kit
- Status
- Available
This fluorescence PCR kit qualitatively detects 14 ROS1 fusion gene mutations in human non-small cell lung cancer (NSCLC) specimens. Results are for clinical reference; not to be used as the sole basis for patient treatment decisions.
| Product type | Assay / Kit |
|---|---|
| Technology platform | Fluorescence PCR |
| Application area | Oncology |
Certificate
CE
Epidemiology
ROS1 is a receptor tyrosine kinase belonging to the insulin receptor family. ROS1 fusion genes represent another key oncogenic driver in non-small cell lung cancer (NSCLC), with an incidence of approximately 1–2%. Rearrangements typically occur within exons 32, 34, 35, and 36, leading to fusion with partners such as CD74, EZR, SLC34A2, and SDC4. These fusions constitutively activate the ROS1 kinase domain, which in turn stimulates downstream signaling cascades including RAS/MAPK/ERK, PI3K/Akt/mTOR, and JAK3/STAT3, thereby driving tumor cell proliferation, differentiation, and metastasis. Among ROS1 fusions, CD74-ROS1 accounts for ~42%, EZR for ~15%, SLC34A2 for ~12%, and SDC4 for ~7%. The ATP-binding pocket of the ROS1 catalytic domain shares 77% homology with that of ALK, enabling ALK inhibitors such as crizotinib to demonstrate significant efficacy in ROS1-fusion-positive NSCLC. Consequently, detecting ROS1 fusion mutations is a prerequisite for guiding crizotinib therapy.
Work Flow
Suggested RNA extraction methods include a silica membrane-based system for formalin-fixed paraffin-embedded (FFPE) tissue and a total RNA purification kit designed for paraffin-embedded tissue sections.
| SKU code | AENE-TM009 |
|---|---|
| Storage | ≤-18℃ |
| Shelf-life | 9 months |
| Specimen Type | paraffin-embedded pathological tissue or sliced 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
Send the essentials for a useful first reply.
Share the application, sample type, format, destination, and expected quantity so AeneBio can route AENE-TM009 to the right quote or sample discussion.