CDx Enzyme Platform for Precision Medicine

Enzymes catalyze reactions that produce measurable outputs such as colorimetric, fluorescent, or chemiluminescent signals.

In CDx assays, enzymes such as HRP and ALP are widely used to convert non-detectable substrates into visible or quantifiable signals. These reactions form the basis of widely adopted detection technologies including ELISA, CLIA, and fluorescence-based assays. The efficiency and kinetics of these enzymatic reactions directly influence signal intensity, detection accuracy, and assay reproducibility.

Through catalytic turnover, enzymes amplify weak biological signals, enabling detection of low-abundance biomarkers.

A single enzyme molecule can catalyze multiple reaction cycles, significantly enhancing signal output from minimal target presence. This amplification is essential for detecting low-copy-number nucleic acids, rare proteins, or early-stage disease biomarkers. Enzyme-driven amplification mechanisms are fundamental to technologies such as PCR/qPCR, enzyme-linked immunoassays, and cascade amplification systems used in advanced biosensors.

Engineered enzymes enhance assay specificity by minimizing background noise and improving target selectivity.

High-purity and optimized enzymes reduce non-specific reactions and improve signal-to-noise ratios, which is critical for accurate clinical interpretation. Additionally, enzyme conjugation strategies (e.g., antibody-enzyme labeling) and substrate selectivity further enhance assay precision. Advanced enzyme engineering enables fine-tuning of catalytic activity and substrate affinity, ensuring reliable performance even in complex biological samples.

Removal of host cell proteins, residual DNA, and process-related impurities to minimize background interference and reduce false-positive or false-negative results in diagnostic assays.

Optimization for thermal resistance, long-term storage, and lyophilization compatibility—ensuring consistent enzyme performance across transportation, storage, and point-of-care testing (POCT) conditions.

Enhancement of catalytic efficiency and substrate affinity to improve assay sensitivity, lower detection limits, and expand dynamic range for low-abundance biomarker detection.

Strict quality control and process standardization to ensure high lot-to-lot reproducibility, supporting reliable assay performance in both research and large-scale diagnostic production.

Our CDx Solutions Include

• Biomarker-driven assay design
  Development of diagnostic assays based on validated biomarkers, enabling accurate patient stratification and targeted therapy selection.
• Enzyme selection and optimization
  Identification and engineering of optimal enzyme systems to enhance sensitivity, specificity, and overall assay performance.
• Diagnostic kit-enabling enzyme supply
  Provision of high-quality, scalable enzyme components suitable for integration into diagnostic kits and commercial workflows.
• Performance validation and optimization
  Analytical validation and iterative optimization to ensure robustness, reproducibility, and consistency across assay conditions and sample types.

Development Value

Our solutions are tailored to accelerate development timelines while reducing technical risk, enabling seamless transition from research to application-ready CDx systems.

Oncology

• Tumor biomarker detection
• Targeted therapy selection

Our platform supports detection of genomic and protein biomarkers associated with cancer progression and therapeutic response, enabling precise patient stratification and improved treatment outcomes in oncology CDx applications.

Infectious Diseases

• Pathogen detection
• Antiviral resistance monitoring

Enzyme-based molecular and immunoassay solutions enable rapid and sensitive detection of pathogens, as well as monitoring of drug resistance markers, supporting timely and effective infectious disease management.

Genetic Disorders

• Mutation analysis
• Inherited disease diagnostics

High-sensitivity enzyme systems support accurate detection of genetic variations, including single nucleotide variants and structural changes, facilitating early diagnosis and risk assessment of inherited disorders.