Companion diagnostic technology platform: From molecular profiling to protein expression
Companion diagnostics is a core component of precision medicine. By detecting specific biomarkers in patients, it provides crucial information for selecting targeted therapies and other treatment options, thereby enabling personalized treatment. The scientific basis of companion diagnostics lies in a deep understanding of the molecular mechanisms of diseases. By detecting specific gene mutations, protein expression levels, or chromosomal translocations in a patient, physicians can accurately predict the pharmacological response of drugs in a particular individual. This process not only significantly improves treatment efficacy and reduces unnecessary toxic side effects but is also an indispensable part of the successful development and commercialization of innovative drugs.
Our technology platform provides a complete solution for this: from NGS technology for large-scale gene variation mapping and discovery of unknown mutations, to dPCR and qPCR technologies for ultrasensitive gene quantification and rapid hotspot mutation screening, and to IHC/ISH technology for in-situ visualization analysis of protein expression levels and gene amplification/fusion. We not only provide these advanced detection technology platforms but also offer clients end-to-end support, from experimental design optimization and key enzyme and reagent supply to technical process standardization and validation, facilitating the development and application of companion diagnostic products.
Figure 1 Companion diagnostics technology platform
(Creative Enzymes Diagnostic)
As a core raw material and technology service provider specializing in companion diagnostics, Creative Enzymes Diagnostic offers a complementary technology platform system based on two core detection dimensions: proteins and nucleic acid molecules.
This platform focuses on the visualization and quantitative analysis of biomarkers in situ within tissues and cells, forming the cornerstone of pathological diagnosis. Leveraging mature immunohistochemistry and in-situ hybridization technologies, we provide end-to-end support from method development to result analysis, accurately assessing key information such as protein expression, gene amplification, and rearrangement. Combining digital pathology and AI image analysis, we assist clients in achieving objective, standardized, and quantitative interpretation of test results, improving diagnostic accuracy and reproducibility.
This platform is dedicated to achieving highly sensitive and specific detection and analysis of gene variations. We provide a complete PCR technology system and next-generation sequencing solutions, covering key applications from rapid hotspot mutation screening and ultra-low frequency mutation quantification to multi-gene parallel analysis and liquid biopsy. We can provide clients with full-chain technical support from detection panel design and experimental workflow optimization to bioinformatics analysis, ensuring stable detection and accurate data interpretation for complex samples.
| Technology Platforms | Detection targets | Sensitivity | Multiple detection capability | Key Advantages |
|---|---|---|---|---|
| Immunohistochemistry/In Situ Hybridization (IHC/ISH) | Protein/specific DNA/RNA sequences | Medium | Low | - Preserves tissue morphology and spatial location information - Gold standard in clinical pathology - Intuitive visualization |
| Fluorescence In Situ Hybridization (FISH) | Specific gene/chromosome sequences | High | Relatively low | - Precisely locates gene mutations within the cell nucleus - Crucial for gene mutations that do not express proteins |
| Next-Generation Sequencing (NGS) | Large-scale nucleic acid sequences | High | Extremely high | - High throughput and comprehensive information - Can detect unknown and rare mutations - Suitable for liquid biopsies |
| Polymerase Chain Reaction (PCR/qPCR) | Specific DNA/RNA fragments | Extremely High | Medium | - Fast speed and lower cost - Excellent sensitivity and specificity - Easy to standardize and widely adopted |
As a core partner in companion diagnostics development, we offer four key supports:
We simultaneously support both nucleic acid (NGS/PCR) and protein (IHC/ISH) detection dimensions, providing a one-stop solution to facilitate multi-omics testing and multi-technology pathway validation.
We provide rigorously quality-controlled diagnostic-grade enzyme raw materials with excellent sensitivity, specificity, and batch stability, specifically optimized to address key detection challenges such as liquid biopsy and low-frequency mutations.
We can provide targeted optimization and co-development of enzyme preparations and detection systems based on your specific biomarkers and performance requirements, helping you overcome technical bottlenecks and build product barriers.
We provide full-process companion services from R&D to application, including methodology optimization, quality standard establishment, and regulatory document support, accelerating the product development and market launch process.
Based on superior raw materials and extended by in-depth cooperation, we are committed to becoming your most trusted partner in developing innovative diagnostic solutions.
Contact our business development team today to discuss your specific project needs!