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Nucleic Acid Drug Biomarker Testing

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Biomarker analysis can be used for exploratory studies, internal decision-making, and as a clinical surrogate endpoint, etc. CD Formulation's bioactivity analytics team is experienced in developing, identifying, and validating biomarkers to provide accurate and reliable information.

About Biomarkers for Nucleic Acid Drugs

A biomarker is a signaling indicator of abnormalities in an organism at various biological levels (molecular, cellular, individual, etc.) due to the impact of environmental pollutants before significant harm occurs. These signaling indicators may include alterations in the structure and function of cellular molecules, changes in biochemical metabolic processes, or the production of abnormal metabolites. Biomarker testing has a wide range of uses, including diagnosing diseases, determining disease stages, evaluating the safety and efficacy of new drugs or therapies in target populations, and assisting researchers in proposing more effective treatments.

Fig.1 Nucleic acid biomarkers. Fig.1 The type of nucleic acid biomarkers. (Gilboa T, et al., 2020)

Our Extensive Nucleic Acid Drugs Biomarker Testing Services

Our biomarker scientists can develop and validate a wide range of biomarker assays for pharmaceutical and biotechnology companies. We are proud to be the preferred choice in this field and to have made a significant impact on our clients. With the addition of multiple technology platforms for biomarker analysis, we believe we will continue to be a leading biomarker testing service provider for years to come.

Our Service Capabilities

Biomarker Discovery

We have extensive experience in biomarker discovery in the fields of oncology, cardiovascular diseases, neurological diseases, metabolic diseases, and other chronic non-communicable diseases. We utilize genomics technology to screen potential biomarker candidates, combined with bioinformatics analysis, to identify key markers with predictive, diagnostic, or efficacy assessment value.

Biomarker Detection

We have established advanced biomarker detection technology platforms such as liquid chromatography-mass spectrometry (LC-MS/MS) and immunoassay. For various types of biomarkers, we can develop sensitive and specific quantitative detection methods, offering high-throughput and high-precision biomarker screening and validation services.

Other Key Experiments

  • Method Development
  • Method Validation
  • Precision/Reproducibility
  • Substrate Parallel Assay
  • Sensitivity/Range
  • Stability and Sample Collection
  • Specificity and Interference
  • Quality Control (inter- and intra-batch experiments)

Delivery of Results

  • Standard project closeout reports.
  • Detailed study reports and test procedures are available upon request for the project.
  • The technical team is available for follow-up study discussions and data exploration with you.

Our Nucleic Acid Drugs Biomarker Analysis Platforms

Our technology platform aids in drug discovery and development, enhances the success rate of clinical trials, and facilitates the planning of companion diagnostic strategies in new drug discovery and development.

Platforms Descriptions
LC-MS/MS LC-MS/MS is the preferred technology for analyzing nucleic acid drug metabolites and targets. By optimizing chromatographic separation and mass spectrometric detection, we can accurately quantify the drug itself, its metabolites, and drug targets such as mRNA and miRNA.
ICP-MS ICP-MS can be used to indirectly quantify the content of drugs and their targets by utilizing metal elements (e.g., phosphorus, sulfur, etc.) in nucleic acid drug molecules as indicators. This technique offers high sensitivity and resolution, making it suitable for analyzing trace amounts of nucleic acids in complex matrices.
ELISA ELISA is a classic immunoassay technique. We have developed ELISA methods for specific nucleic acid drugs with good specificity and sensitivity.
ELLA Compared with ELISA, ELLA has higher sensitivity and throughput, making it suitable for analyzing nucleic acids in complex biological samples.
MSD MSD (Meso Scale Discovery) is an electrochemiluminescence-based assay that enables highly sensitive and specific analysis of nucleic acid drugs and their biomarkers. The platform supports multi-parameter analysis, which is conducive to studying the pharmacokinetics and pharmacodynamics of nucleic acid drugs.

Our Workflow for Nucleic Acid Drugs Biomarker Analysis

Fig.2 Workflow of nucleic acid biomarkers analysis.Fig.2 Flow chart of nucleic acid drugs biomarker assays. (CD Formulation)

Sample Collection

During the sample collection phase, we will establish suitable pre-treatment procedures tailored to the characteristics of the indicator being tested. These procedures may involve sample separation, extraction, and purification to ensure the accuracy and reliability of the final analysis.

Biomarker Detection

For biomarker detection, we will utilize the most appropriate technology to identify and quantitatively analyze a range of biomarkers.

Data Analysis

We will employ a range of analytical tools and software to extract critical information from the data and conduct trend analysis and comparisons.

Results Reporting

Our reports include the experimental design, assay methodology, data results, and their interpretation, ensuring that you have a comprehensive understanding of every aspect of the study.

Why Choose Us for Nucleic Acid Drugs Biomarker Analysis?

  • Multiple Biomarker Analysis Methods
    We specialize in developing and validating methodologies for biomarkers using various detection platforms and levels. Our services offer a wide range of methods, quicker detection, and more efficient cost control tailored to meet our customers' research requirements.
  • Multi-Background Research Team
    Our nucleic acid biomarker platform team has diverse backgrounds in molecular biology, molecular pharmacology, oncology, immunology, and bioinformatics, offering data-driven support for translational medicine.
  • Bioinformatics Solutions
    Advanced bioinformatics solutions help scientists analyze complex data sets to quickly and efficiently identify potential biomarkers.

Publication Data

Technology: Single-molecule in vitro and in situ analysis techniques for nucleic acid biomarkers.

Journal: Analytica Chimica Acta

IF: 6.91

Published: 2020

Results:

Nucleic acids are important biomarkers for the detection, monitoring and treatment of diseases. Advances in nucleic acid analysis technology have facilitated the discovery and clinical application of nucleic acid biomarkers. However, nucleic acid analysis technologies still face challenges that limit the application of nucleic acid biomarkers in certain situations. Here, the authors review single-molecule techniques for nucleic acid analysis that can be used to overcome these challenges. The authors first discuss the various types of nucleic acid biomarkers that are important for clinical applications as well as the traditional techniques for nucleic acid analysis. Then, the authors discuss single-molecule in vitro and in situ analysis techniques for nucleic acid biomarkers. Finally, the authors discuss other ultrasensitive techniques for nucleic acid biomarker detection.

Fig.3 Nucleic acid biomarkers analysis.Fig.3 Single-molecule analysis of nucleic acid biomarkers. (Gilboa T, et al., 2020)

CD Formulation offers solutions that tackle the main challenges in biomarker discovery and validation: throughput, reliability, sensitivity, and ease of use. Contact us for your nucleic acid drug biomarker needs.

Reference

  1. Gilboa T, Garden P M, Cohen L. Single-molecule analysis of nucleic acid biomarkers - A review. Anal. Chim. Acta. 2020, 1115: 61-85.
How It Works
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