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Views: 0 Author: Site Editor Publish Time: 2026-09-04 Origin: Site
Cobioer Gene provides combined positive and negative TF (Tissue Factor) IHC controls in two formats: FFPE tissue blocks and pre-cut FFPE control slides. The controls are validated by immunohistochemistry for routine quality control of TF IHC assays and companion diagnostic assay development. For Research Use Only.
TF (Tissue Factor) IHC Quality Controls - For Routine Immunohistochemistry Quality Control and Companion Diagnostic Development
Tissue Factor (TF), also known as coagulation factor III or CD142, is a 43 kDa transmembrane glycoprotein encoded by the F3 gene. Under physiological conditions, TF expression is restricted to the vascular adventitia, where it initiates the extrinsic coagulation pathway. In several solid tumors, however, TF is aberrantly overexpressed through mechanisms driven by HPV E6/E7, hypoxia, inflammatory signaling, and other factors. These tumors include cervical cancer, pancreatic cancer, colorectal cancer, non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and glioblastoma. High TF expression is often associated with advanced disease stage, lymph node metastasis, poor differentiation, an increased risk of venous thromboembolism (VTE), and shorter overall survival.
In June 2026, the TF-targeting antibody-drug conjugate Tisotumab vedotin (Tivdak®; Chinese brand name, transliterated: Ti Le®) was approved by the National Medical Products Administration (NMPA) for recurrent or metastatic cervical cancer. It became the first ADC approved for cervical cancer in China and the first ADC to bring the concept of TF as an IHC-detectable target into a prominent clinical role. Companion diagnostic (CDx) assay development places more stringent requirements on the accuracy, repeatability, and standardization of IHC testing.
To support routine quality control of TF IHC assays and companion diagnostic development, Cobioer Gene offers two ready-to-use IHC controls:
1. TF Positive/Negative FFPE Tissue Block Control (CBPN0079) - An FFPE tissue block containing TF-positive and TF-negative control tissues, ready for sectioning.
2. TF Positive/Negative Pre-Cut FFPE Control Slides (CBPN0080) - Pre-cut slides containing TF-positive and TF-negative control tissues, supplied ready to use.
Product data are shown below:
TF Positive/Negative FFPE Tissue Block Control - CBPN0079
TF Positive/Negative Pre-Cut FFPE Control Slides - CBPN0080
For Research Use Only. Not for use in diagnostic procedures. This product is not intended to replace national reference materials for regulatory registration.
Combined positive and negative control - Each control slide or tissue block contains both TF-positive and TF-negative control tissues, allowing them to be stained together and compared directly.
IHC-validated - The controls are validated by immunohistochemical staining with a TF-specific antibody to confirm clear differentiation between positive and negative tissues and low background staining. Product validation data are provided.
Two formats available - The FFPE tissue block (CBPN0079) allows flexible sectioning, while the pre-cut FFPE control slides (CBPN0080) are ready to use and suited to standardized workflows.
Designed to reflect clinical specimens - The tissue sources and processing methods are consistent with those used for clinical FFPE specimens, reflecting staining performance under routine testing conditions.
Lot-to-lot consistency - Defined quality control standards are applied to support stable and reliable staining performance across different lots.
In-stock availability - Routine inventory and prompt shipment support time-sensitive research and production needs.
Combined positive and negative controls for efficient side-by-side comparison - Each control slide or tissue block contains both TF-positive and TF-negative control tissues. The tissues can be stained and interpreted together under the same conditions, reducing interference from between-batch variation and improving the accuracy and confidence of result interpretation.
Rigorous IHC validation supported by product data - Each lot is validated by immunohistochemistry using a TF-specific antibody. The positive control is assessed for clear staining and appropriate localization, while the negative control is assessed for clean background and the absence of nonspecific staining. A product validation data report is provided.
FFPE tissue blocks and pre-cut slides for different workflows - Two formats are available: an FFPE tissue block control (CBPN0079) for flexible sectioning and ready-to-use pre-cut FFPE control slides (CBPN0080). Together, these formats support both exploratory studies and standardized routine quality control.
Clinical-specimen-like FFPE controls for more representative quality control - The tissue sources and the fixation, embedding, and sectioning processes match those used for clinical specimens as closely as possible. This allows staining performance to be assessed under representative testing conditions and helps avoid the "idealized" bias that may arise with cell line- or recombinant protein-based controls.
Lot-to-lot consistency and long-term stability - A controlled quality management system supports consistent staining performance across lots. Recommended storage at 2-8°C helps maintain reproducible results during extended use.
In-stock availability and prompt response - Routine inventory reduces lead times and supports urgent research needs and production schedules.
Technical support throughout assay setup - Complimentary pre- and post-sale technical support is available, including antibody recommendations, staining protocol optimization, and troubleshooting, to help customers establish a reliable and stable TF IHC assay.
The approval of Tisotumab vedotin has brought TF IHC testing into the companion diagnostic landscape. The innovaTV 301 study showed a significant association between TF expression intensity, measured by H-score, and treatment response: the objective response rate (ORR) exceeded 30% among patients with H-score ≥ 150, compared with less than 10% in the low-expression group. During development of a TF IHC CDx kit, these controls can be used for assay optimization, staining parameter selection, and establishment of interpretation criteria, as well as evaluation of performance characteristics such as accuracy, repeatability, and intermediate precision, to support reliable test results for clinical decision-making.
For pathology laboratories that currently perform or plan to perform TF IHC testing, routine quality control is fundamental to accurate results. Staining these combined positive and negative controls alongside patient specimens enables direct monitoring of key variables, including antibody lot variation, staining platform performance, antigen retrieval efficiency, and detection system stability. When abnormal staining occurs, the controls can help identify the likely source, such as antibody failure, reagent contamination, or instrument malfunction, and help prevent invalid results from being reported.
TF is not only a therapeutic target but also an important marker for prognostic stratification and thrombotic risk. In a pancreatic cancer study, median overall survival (OS) was significantly shorter in the high-TF-expression group (20.6 months) than in the low-expression group (38.8 months) and the negative group (53.6 months), with a hazard ratio (HR) of 2.21. In liver cancer, lung cancer, breast cancer, and glioma, high TF expression has been associated with increased microvessel density, invasion and metastasis, and poor prognosis. In addition, exposure of TF on the tumor-cell surface contributes to cancer-associated hypercoagulability and increases the risk of VTE and disseminated intravascular coagulation (DIC). These controls can be used as quality control tools for prognostic biomarker research and analyses of associations with thrombotic risk, supporting reliable and reproducible IHC staining data.
1. What tissues are used as the positive and negative controls in the combined TF-positive and TF-negative control?
The positive control is tumor tissue known to have high TF expression, specifically IHC-validated cervical cancer or pancreatic cancer tissue. The negative control is benign or normal tissue known to lack TF expression. The positive and negative tissues are positioned adjacent to each other within the same control, allowing their staining results to be compared on the same slide.
2. What is the difference between the FFPE tissue block control (CBPN0079) and the pre-cut FFPE control slides (CBPN0080)?
CBPN0079 is an unsectioned FFPE tissue block that users can section as needed, making it suitable for flexible study designs. CBPN0080 consists of pre-cut, ready-to-use slides suited to standardized workflows and routine quality control, reducing the need for sectioning time and equipment.
3. Have these controls been validated by IHC, and which antibody is recommended?
Yes. Each lot is validated by IHC using a specific anti-TF antibody to confirm clear differentiation between positive and negative tissues. Customers are advised to perform preliminary validation using their own detection system. They may also contact us for the recommended antibody clone and validation data.
4. Can these controls be used in a regulatory submission for a Tisotumab vedotin companion diagnostic?
This product is For Research Use Only and is not intended to replace national reference materials for regulatory registration. Formal registration studies should use approved reference materials under the guidance of the Center for Medical Device Evaluation of the National Medical Products Administration (CMDE, NMPA).
5. How can I request a quotation, technical information, or an evaluation sample?
Please email info@cb-gene.com or visit our website. Complimentary technical consultation and product information are available.
