Biomarker Testing

Biomarker Analysis Services

Analytical Techniques

Biomarker Assay Platforms

FDA Guidance

Biomarker Analysis Services

Biomaker is a measurable indicator of some biological state or condition. So Biomarker is a key medical development tool capable of facilitating development of medical products and spurring innovation. When used in the right context, biomarkers have the potential to help expedite patient access to safe and effective treatments by reducing the time and cost of clinical trials while maintaining patient protections. Biomarkers can facilitate the development of new drug, and help patient access to safe and effective treatment. Scientists have performed bioanalytical method development for different biomarkers such as proteins, peptides and carbohydrates using LC/MS/MS, ELISA and MSD.

Analytical Techniques Available

MSD-ECLA in Discovery of Biomarker
The multiplexing feature of the MSD-ECLA platform makes discovering biomarkers quicker and more accurate than ever before.  Different analytes can be tested in a single well.  MSD sells kits specifically designed for screening biomarkers.  Rapid screening of proteins can expedite your search for clinical relevant end-points. We can develop and validate single or multiplex MSD-ECLA assays for a range of analytes in complex sample matrices such as serum, plasma, urine, and cell culture mixtures. We can develop custom MSD assays based on client requirements and validate them according to GLP or GMP if needed.

ELISA in Discovery of Biomarker
Enzyme-linked immunosorbent assay (ELISA) is a biochemical technique used mainly in immunology to detect the presence of an antibody or an antigen in a sample. Biomarker is a substance which exists in serum or other living organism, so biomarker usually is used to measure the transformation of biological system, organ, tissue, subcellular structure or their function. We have developed more than 10 ELISA detection platforms used to detect the traceable biomarkers and give the clinical evaluation on safety and toxicity data.

Biomarker Assay Platforms

More analytical technologies with high accuracy and sensitivity can be used in large molecules, biological therapeutics and ligand binding assay. We will provide solution to help you find the best analytical platform not only for your project in early or late stage of drug discovery but also in the preclinical and clinical phase. The followed platforms listed below have been successfully proven to determine biomarkers in the specific biological samples.



Bio-Plex Liquid Array Multiplexing System

Regulatory Guidance

FDA Biomarker Qualification Program

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