Molecular Diagnosis and Nucleic Acid Platform Development Services

Molecular diagnostics represents a transformative approach to disease management, public health, and biological research. By analyzing biological markers at the molecular level, specifically nucleic acids (DNA and RNA), these techniques provide unparalleled precision for detecting pathogens, identifying genetic mutations, and profiling gene expression. The effectiveness of molecular diagnostics is intrinsically linked to the nucleic acid platforms that underpin them. These platforms encompass the entire workflow—from sample preparation and nucleic acid extraction to amplification, detection, and data analysis.

Figure 1. Magnetic Bead.

Overview

CD Bioparticles is a leading provider of advanced materials and custom services for the life sciences sector. We specialize in the design, development, and manufacturing of high-performance components that form the backbone of modern diagnostic and research tools. Our molecular diagnosis and nucleic acid platform development services leverage our deep expertise in polymer science, surface chemistry, and nanobiotechnology to create robust, sensitive, and reliable solutions tailored to our clients' specific needs. We partner with diagnostic companies, research institutions, and biotech firms to accelerate the development and commercialization of next-generation molecular assays and diagnostic systems.

Our Services

CD Bioparticles offers a comprehensive suite of services to support every stage of your molecular diagnostic and nucleic acid platform development project. Our approach is collaborative and customized, focusing on translating your assay concept into a viable, high-performance product.

Custom Nucleic Acid Extraction and Purification Solutions

We design and manufacture specialized magnetic beads and particles for the isolation of DNA and RNA from diverse sample types (blood, saliva, tissue, environmental swabs). Our services include:

• Surface Coating and Functionalization: Modifying particle surfaces with silica, carboxyl, or other ligands to optimize binding capacity and purity.
• Size and Magnetic Responsiveness Tuning: Engineering particles of specific sizes and magnetic properties to facilitate rapid separation and integration into automated systems.
• Formulation Development: Creating ready-to-use lysis/binding buffers and wash solutions tailored to your specific sample matrix.

Development of Solid-Phase Assay Platforms

We assist in creating robust solid supports for various assay formats:

• Microarray and Biochip Development: Functionalizing glass slides, membranes, or plastic substrates with high-density oligonucleotide probes. We optimize surface chemistry to maximize probe binding efficiency and minimize non-specific background noise.
• Lateral Flow Assay (LFA) Development: Designing conjugate pads and membranes for nucleic acid-based lateral flow tests, incorporating gold nanoparticles or fluorescent microspheres as detection labels.
• Microplate-Based Assay Development: Coating ELISA plates or other microplates to create stable platforms for hybridization or capture assays.

Design and Synthesis of Specialized Oligonucleotides

Beyond standard primers and probes, we provide advanced oligonucleotide services:

• Probe Labeling: Conjugating oligonucleotides with a wide range of fluorophores, quenchers, biotin, or other haptens.
• Modification: Incorporating locked nucleic acids (LNAs) to enhance hybridization affinity and specificity, or adding spacers and linkers for optimal surface immobilization.

Assay Optimization and Integration

Our team provides expert support in integrating our components into your final assay system:

• Buffer and Master Mix Optimization: Formulating amplification mixes that are compatible with our solid supports and functional particles to ensure high sensitivity and reproducibility.
• Protocol Development: Establishing standardized operating procedures for sample preparation, amplification, and detection.
• Analytical Performance Testing: Conducting studies to validate key parameters such as limit of detection (LoD), specificity, sensitivity, and dynamic range.

Scale-Up and GMP Manufacturing

Once a prototype is validated, we support the transition to commercial production:

• Pilot-Scale Production: Manufacturing batches for clinical validation and pilot studies.
• cGMP Manufacturing: Producing high-volume, consistent, and quality-controlled materials under current Good Manufacturing Practices (cGMP) for in vitro diagnostic (IVD) applications.
• Quality Control and Lot Consistency: Implementing rigorous QC protocols to ensure every batch meets predefined specifications.

Applications

The services offered by CD Bioparticles enable advancements across a broad spectrum of fields:

• Infectious Disease Diagnostics: Developing rapid, sensitive tests for viruses (e.g., SARS-CoV-2, HIV, Influenza), bacteria, and parasites for point-of-care and central laboratory use.
• Oncology: Creating platforms for cancer genotyping, detection of circulating tumor DNA (ctDNA) for liquid biopsies, and profiling gene expression patterns.
• Genetic Testing: Supporting the development of tests for hereditary disorders, pharmacogenomics (predicting drug response), and carrier screening.
• Food Safety and Environmental Monitoring: Designing assays for the detection of pathogenic contaminants in food and water samples.

Our Process

Our approach is highly collaborative, ensuring the final product meets your exact specifications:

Our Advantages

The advancement of molecular diagnostics hinges on the continuous innovation of the underlying nucleic acid platforms. These platforms must become more sensitive, faster, easier to use, and more cost-effective to meet the growing demands of personalized medicine and global health. CD Bioparticles is uniquely positioned to be your strategic partner in this endeavor. Our specialized knowledge in creating high-quality, functional materials, combined with our comprehensive development services, provides the essential foundation for building superior diagnostic products.