Today’s scientific community believes biomarkers may help fulfill the unmet diagnostic needs for numerous complex diseases. However, the current biomarker research landscape faces skepticism due to higher failure rates of biomarker studies. On average, the US FDA approves 1-3 biomarkers a year. Besides, several putative biomarker studies fail in the verification and validation stages. Hence, there is a growing need for adopting robust biomarker studies in the drug discovery and development process.
Many major players, such as MesoScale technology (MSD) and Luminex assay services, have platforms for biomarker research. Their applications include Luminex cytokine assay and MSD immunogenicity assays. Both these platforms have their unique advantages. The current article focuses on identifying the apt MSD biomarker for research studies.
Apt MSD biomarker in research
The biomarker discovery phase has several inherent obstacles that lead to failure in developing robust clinical biomarkers. The primary reasons for biomarker bummer lie in the exploratory phases. Besides, there are several reasons for the failure of a biomarker candidate early in the discovery phase. These flaws include underpowered and poorly designed studies, assay variability, inappropriate data analysis, incorrect interpretation, and inadequate expertise.
MSD protocol is a unique multiplex approach for quantifying biomarkers in biological samples. MSD has over 400 assays and customization capabilities that empower scientists to determine biomarkers accurately in different study matrices. These features have made MSD assays the primary choice of detection platform for major pharmaceutical and biotech companies, clinical research organizations, and government and academic institutions.
MSD employs electrochemiluminescence technology to detect biomarkers through both single and multiplex formats. The platform combines patterned arrays and electrochemiluminescence detection to provide highly dense data through organization, miniaturization, and parallel processing of study samples.
The multi-array plates are the hallmark of MSD assays. These arrays facilitate the detection of multiple analytes in a single assay volume. MSD assays offer ultra-low detection, use minimal samples, provide a broader dynamic range and work well with complex study matrices. These unique features allow the detection and quantification of native biomarkers in diseased and normal samples without multiple dilutions. Moreover, the MSD protocol is simple and reduces assay workflow, and eliminates unnecessary experimental costs.
Also Read: 7 Norms Meso Scale Diagnostics Must Follow
Clinical samples are inherently complex. Analyzing these complex samples may be challenging with traditional immunoassays such as RIA and ELISA. Besides, various study matrices such as vaginal fluids and sputum, limited sample volumes, and wide dynamic range make assessing samples through conventional assays even more challenging. MSD biomarker assays easily overcome these challenges. MSD assays have a broader dynamic range, improved sensitivity, and multiplexing capacities and handle complex study matrices. Moreover, these assays are suitable for regulated workflows and support GLP and 21 CFR Part 11 compliance.
Some promising characteristics of MSD biomarkers include:
- A broader dynamic assay range enables the analysis of biomarkers in study samples without the need for multiple dilutions
- Highly adaptable to quantify analytes in complex biological matrices
- Multiplexing abilities allow scientists to assess several biomarkers in a single assay volume
Thus, MSD biomarker assays are a robust platform for assessing multiple biomarkers in biological samples.
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