Biomarker Discovery and Development
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Biomarker Discovery and Development

The discovery and development of biomarkers lead to meaningful developments in the diagnosis of diseases. Using advanced technologies together with a team of professional specialists, we assist clients in identifying and discovering candidate biomarkers with the objective of further advancing the development of diagnostic assays.

What are Biomarkers?

Biomarkers, measurable indicators of particular biological processes or disease states, have emerged as useful adjuncts in the diagnosis of infectious diseases. They are of assistance in the determination of whether the infection is present, its stage and its severity. The following are the advantages of biomarkers in infectious disease diagnosis.

  • Firstly, they allow for early detection and intervention, enabling prompt initiation of appropriate therapeutics and preventing disease progression.
  • Second, they improve the accuracy and specificity of distinguishing among different pathogens which assist in selecting the correct type of therapy.
  • Besides, biomarkers can act as prognostic factors, aiding in gauging disease prognosis and mapping out customized therapies.

Key steps in biomarker discovery and development.Fig. 1 Stages of biomarker discovery and development. (Menetski J P, et al., 2019)

Types of Biomarkers

Different biomarker types assist in the diagnosis of infectious diseases and shed light on the pathological mechanisms involved.

Molecular tests.Genetic Biomarkers

Nucleic acids including DNA and RNA, which are classified as genetic biomarkers, are said to possess unparalleled sensitivity and specificity when distinguishing and identifying pathogens as well as their antibiotic resistance profiles and genetic variations.

Serological tests.Protein Biomarkers

These biomarkers are specific proteins or peptides whose presence or levels can indicate the presence of an infectious agent, provide information about the disease progression, or predict treatment response.

Genetic testsMetabolic Biomarkers

Metabolite biomarkers are detectable and quantifiable small molecules or metabolites microscopically. They aid in determining the source of infection, and are non-invasive and easy to detect.

Typical Biomarkers for Infectious Disease Diagnosis

Here are some examples of typical biomarkers used in infectious disease diagnosis.

Infectious Diseases Typical Biomarkers
Human Immunodeficiency Virus (HIV) HIV antibody, p24 antigen
Hepatitis B Virus (HBV) Hepatitis B surface antigen (HBsAg), anti-HBc antibodies
Hepatitis C Virus (HCV) HCV antibody, HCV RNA
Tuberculosis (TB) Interferon-gamma
Coronavirus Disease 2019 (COVID-19) SARS-CoV-2 viral RNA, nucleocapsid protein

Our Services

In the field of infectious diseases diagnostics, the finding and development of specific biologic markers has great potential. Our company is the leader in this field and provides one stop services for all the aspects of biomarker discovery and development. With such great experience and commitment, we work towards VISION of enabling the use of biomarkers as a game-changing tool in addressing the problem of diagnosing infectious diseases.

Workflow of Biomarker Discovery and Development

Biological Sample Collection and Processing

  • Sample Collection: As per the requirements of the research study, biological samples like blood, tissue, or urine are normally gathered.
  • Sample Processing: The collected samples are processed further in order to perform further analysis. Processing steps include centrifugation, aliquoting, storage, etc.

Biomarker Discovery

  • High-Throughput Screening: Genomic, proteomic and metabolomic high-throughput screening tools are utilized for analysis of large numbers of biological samples for the purpose of biomarker identification.
  • Bioinformatics Analysis: This component includes the pre-processing, analysis and mining of the large sets of data created during high throughput screening towards ascertaining probable biomarkers and understanding their significance in biology.

Biomarker Validation

  • Biological Effect Validation: Validation of biological effects of potential biomarkers by testing them in animal or human in vitro models, including determining the levels or presence of biomarker in certain tissues or biological fluids. This also aids to investigate its functional profile or mechanism of action.
  • Validation of Clinical Sample: This entails evaluation of patient's clinical samples known to have the disease of interest and measurement and comparison of biomarker levels across patients. A statistical evaluation is done on the sample to ascertain the diagnostic or prognostic capacity of the biomarker.

Biomarker Assay Development

  • Technology Selection: Aiming for ELISA, PCR or biosensors as the test technology as per the characteristics of the biomarker and the requirements of the assay.
  • Method development: This involves optimizing detection conditions, designing primers or probes, and establishing calibration curves to ensure the accuracy, sensitivity, specificity and stability of biomarker detection.

Optional Biomarkers

At our company, we provide discovery, validation and assay development services for a wide variety of biomarkers.

  • DNA and RNA
  • Antigen
  • Antibody
  • Metabolite
  • Microorganism
  • And More

Our Advantages

If you are interested in our services, please feel free to contact us for more details and quotation information of related services.

References

  1. Menetski J P, Hoffmann S C, Cush S S, et al. The Foundation for the National Institutes of Health Biomarkers Consortium: past accomplishments and new strategic direction[J]. Clinical Pharmacology & Therapeutics, 2019, 105(4): 829-843.
  2. Davis K D, Aghaeepour N, Ahn A H, et al. Discovery and validation of biomarkers to aid the development of safe and effective pain therapeutics: challenges and opportunities[J]. Nature Reviews Neurology, 2020, 16(7): 381-400.

All of our services and products are intended for preclinical research use only and cannot be used to diagnose, treat or manage patients.