Enzyme Engineering for CDx: Purity, Stability, and Performance

Background

In the era of precision medicine, companion diagnostics, as a core technology of this revolution, is a prerequisite for effective targeted therapy. It screens patients most likely to benefit from corresponding drugs by detecting specific biomarkers (such as gene mutations and protein expression) in their biological samples before medication, thereby improving efficacy and avoiding ineffective treatments and side effects. The successful development and stable application of companion diagnostic reagents highly depend on the performance of their core biological tool—enzymes. From sample processing to signal readout, the accuracy, sensitivity, and stability of each step are directly determined by the enzymes used. Therefore, enzymes optimized specifically for companion diagnostics must achieve industrial standards far exceeding research-grade levels in purity, stability, specificity, and consistency.

Figure 1 Companion diagnostics technology platform
(Creative Enzymes Diagnostic)

Creative Enzymes Diagnostic, as an enzyme raw material supplier, is a solution provider and partner for the entire process of companion diagnostics (CDx) development. We possess leading enzyme engineering platforms, diagnostic-grade production quality control systems, and in-depth application support. We also offer Enzymes for Companion Diagnostics (CDx) products, providing comprehensive support from R&D to the end user.

Companion Diagnostic Key Enzymes

1. High-fidelity DNA polymerase: In gene mutation detection, any error introduced by the polymerase itself can lead to false positives or false negatives.

• Ultra-high fidelity: Extremely low error rate is the fundamental guarantee for detecting low-frequency mutations.
• Powerful continuous synthesis capability: Capable of efficiently amplifying clinical sample DNA with complex secondary structures or high GC content.
• Excellent inhibitor tolerance: Insensitive to common inhibitors in blood samples such as heparin and hemoglobin, ensuring reliable results.

2. Reverse transcriptase: Stably captures RNA biomarkers; many important companion diagnostic biomarkers are derived from RNA (such as gene fusion transcripts and certain expression level markers).

• High thermal stability: Allows reverse transcription at higher temperatures, effectively opening up the complex secondary structures of RNA, improving the yield and specificity of full-length cDNA, especially crucial for the detection of long-fragment fusion genes.
• High sensitivity and efficiency: Capable of efficiently converting trace amounts and partially degraded clinical RNA samples.
• RNase H-free: Prevents degradation of the RNA template during synthesis, increasing yield and length.

3. Isothermal Amplification Enzymes: Enables rapid on-site detection. For rapid companion diagnostics in primary healthcare settings or point-of-care testing (POCT), isothermal amplification technologies (such as RPA and LAMP) that do not require thermal cycling instruments are crucial.

• Rapid Start-up and High Amplification Efficiency: Achieves detectable signals quickly to meet the demands of rapid diagnosis.
• Strong Strand Displacement Activity: Unwinds DNA double strands without thermal denaturation, a core function of most isothermal amplification technologies.
• Excellent Lyophilization Compatibility: Enables the preparation of room-temperature stable lyophilized microspheres or powders, greatly simplifying procedures and ensuring long-term reagent stability.

4. Modification and Nucleic Acid Processing Enzymes: Including ligases, phosphorylases, UDG/UNG, and specific nucleases, ensuring system cleanliness and signal accuracy. The high performance of companion diagnostic systems relies heavily on the precise coordination of a series of "auxiliary" enzymes.

• Absolute Purity and No Contamination: Ensures no introduction of exogenous nucleases or nucleic acids that could interfere with detection.
• High Specific Activity: Works efficiently even in complex diagnostic reaction systems.
• Strict quality control standards: no host residue, low endotoxins, and compliance with regulatory requirements for raw materials for in vitro diagnostic reagents.

Our Core Advantages

We focus on providing highly reliable, stable, and ready-to-use core enzyme solutions for companion diagnostics (CDx) development. Our core advantages are:

Figure 2 Our companion diagnostic enzyme advantages
(Creative Enzymes Diagnostic)

Creative Enzymes Diagnostic is committed to becoming your trusted partner, helping your diagnostic innovations to be successfully implemented with superior raw materials and professional insights.

Contact our business development team today to discuss your specific project needs!

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