TPM3-NTRK1 Fusion RNA Standard: Reliable Positive Control for Precision Oncology Research

Product Overview

The TPM3-NTRK1 Fusion RNA Standard is a rigorously designed and validated molecular reference material, established to serve as a gold standard for laboratory-based NTRK gene fusion detection.

Core Composition: This product consists of RNA molecules comprising a specific fusion transcript of the TPM3 and NTRK1 genes.

Left Gene: TPM3 (Tropomyosin 3), derived from chromosome 1 (chr1:154142876), with a breakpoint in exon 7 (E7). TPM3 is a member of the actin-binding protein family, playing a key role in cytoskeletal regulation and embryonic development. When fused to NTRK1, it acts as a potent oncogenic driver.

Right Gene: NTRK1 (Neurotrophic Receptor Tyrosine Kinase 1), derived from chromosome 1 (chr1:156844363), with a breakpoint in exon 10 (E10). The NTRK1 gene encodes the Tropomyosin Receptor Kinase A (TRKA) protein.

Fusion Type: This standard accurately mimics the classic TPM3(E7)-NTRK1(E10) fusion variant (COSMIC ID: COSF1329), a recurrent alteration identified in colorectal cancer and other tumor types, ensuring high clinical relevance.

Technical Specifications

Format: High-purity RNA, resuspended in RNase-free water to ensure stability.

Source: Human gene-derived.

Molecular Identifier: Corresponds to reference transcripts NM_001043351.2 (TPM3) and NM_002529.3 (NTRK1).

Quality Control: Each batch is rigorously validated for concentration, purity (A260/A280), RNA integrity via electrophoresis, and sequence accuracy via Sanger sequencing. The Certificate of Analysis (COA) is available for download.

Storage & Shelf Life: Store at -90°C to -70°C. The product is stable for 12 months from the date of manufacture.

Intended Use: This product is intended for Research Use Only (RUO). It is an ideal positive control for optimizing and validating molecular assay platforms such as RT-PCR, qPCR, Digital PCR, and Next-Generation Sequencing (NGS).

Product Features

High Accuracy and Reliability

This standard precisely recapitulates the key breakpoint of the TPM3-NTRK1 fusion, providing laboratories with a sample of "known answer." Using it as a positive control allows for effective assessment of assay sensitivity, specificity, and reproducibility, fundamentally preventing false-negative and false-positive results and ensuring data accuracy.

Broad Platform Compatibility

The standard is compatible with a wide range of platforms, from traditional Sanger sequencing to high-throughput NGS and various PCR-based methods. Researchers can use it to establish, optimize, and standardize their in-house NTRK fusion detection protocols, accelerating R&D cycles.

Exceptional Stability and Convenience

As a ready-to-use RNA standard, it eliminates the need for cell culture or RNA extraction, saving time and reducing the risk of cross-contamination. Stringent QC and clear storage guidelines guarantee consistent performance throughout its shelf life, ensuring comparability of experimental results.

Robust Quality Control and Traceability

Each batch is accompanied by a detailed Certificate of Analysis (COA), including data on concentration, purity, and RNA integrity. Its associated COSMIC ID (COSF1329) facilitates academic citation and data traceability, enhancing the credibility of research findings.

Driving Advancements in Precision Medicine

NTRK fusions are a paradigm of the "tissue-agnostic" oncology approach. A reliable detection standard is the cornerstone for advancing the clinical use of NTRK inhibitors and enabling effective "histology-independent" treatment. This product provides an indispensable tool for drug development, companion diagnostic assay development, and basic translational research

Usage

Routine QC Implementation

Its primary applications are in molecular diagnostic labs and research institutions, where it serves as a Positive Control and Quality Control Material for:

•Developing and validating RNA-based NTRK gene fusion detection assays

•Monitoring the stability and accuracy of routine testing procedures.

•Training laboratory personnel to ensure operational consistency.

•Proficiency testing and external quality assessment schemes.

Validation Studies

Incorporate into assay validation to demonstrate:

• Concentration (60.00 ng/uL±10%)

• OD₂₆₀/OD₂₈₀ (1.8~2.2)

• RQN value (≥8)

• Copy number

• Genotype

FAQ

Is the product a DNA or RNA standard? Why is it formatted as RNA?

This product is an RNA standard. The RNA format is chosen because many highly sensitive NTRK fusion detection methods (e.g., RT-PCR, RNA-Seq) target the fusion gene's transcript (mRNA). An RNA standard can be directly incorporated into these workflows, mimicking the real sample testing process, yielding more direct and reliable results.

How should I store and handle this standard?

The product is sensitive to RNases and must be stored frozen at -90°C to -70°C. During use, keep it on ice and avoid repeated freeze-thaw cycles. Brief centrifugation before opening and aliquoting is recommended for maximum stability.

In which cancer types is this fusion commonly found?

The TPM3-NTRK1 fusion is a well-characterized oncogenic driver, recurrently reported in colorectal cancer, and has also been identified in various other malignancies, including congenital fibrosarcoma, papillary thyroid carcinoma, and lung adenocarcinoma. Using this standard aids in detecting this relevant fusion event across these cancer types.

Where can I find the concentration and purity information for my product vial?

Each standard is accompanied by a unique Certificate of Analysis (COA). You can download the COA from the product webpage or via the provided link. The COA details the specific concentration, purity (A260/A280 ratio), RNA integrity number (RIN) equivalent data, and other critical quality control metrics for your batch.

Technical Data

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If you have any questions, please feel free to contact us at sales@cb-gene.com