Creative Biolabs offers biomarker analysis services through a network of experts familiar with the multifaceted nature of biomarker selection, validation, and application from drug discovery to in vitro diagnostics (IVD) supporting decision-making and mitigating risk at key stages of your program. Creative Biolabs is well positioned to assist you with customized biomarker solutions for sample analysis needs.
Importance of Biomarker Analysis
A biomarker is defined as a characteristic that is objectively measured and evaluated as an indicator of normal biological processes as well as pathogenic ones. Biomarker assays and analytical data are important tools in drug discovery from target validation studies to candidate selection. Analysis services are used extensively in the earlier stages of the drug discovery process for mechanistic or pharmacodynamic purposes such as determining the mechanism of action (MOA), validating drug targets, monitoring therapeutic responses, and guiding compound selections. Thus, biomarker analysis services help decide whether potential therapeutic agents should be discontinued or pursued further.
Objects for Biomarker Detection
Though biomarkers can be any molecule that indicates a biological state, proteins are generally of greatest importance in life science research. The most common strategy for protein biomarker analysis is the use of commercially available kits. However, we are also experienced with making biomarker assays tailored for customers. There are two basic formats for biomarker analyses, namely Singleplex and Multiplex assays. Single analyte commercial kits are very useful but can vary greatly regarding specificity, sensitivity, and availability. Creative Biolabs has experience with a broad array of biomarkers from many kits and reagent vendors and can identify the best option(s) for your biomarker project.
Fig.1 Some hot research targets.
Biomarker Testing Services
Optimal biomarker assays create a knowledge framework for confident decision-making to help minimize risk. With techniques shown in Fig.3, Creative Biolabs will use appropriate approaches to analyze biomarkers. We have also invested in the field of multiplexing, using the bead-based and ECL-based platforms to offer robust immunoassays. Scientists at Creative Biolabs have worked with over 500 analytes in singleplex and multiplex formats across a wide range of disease areas. From assay qualification to full validation, our experts propose fit-for-purpose analysis fully adapted to the context of the use of your biomarkers. We offer a comprehensive range of biomarker services in key therapeutic areas and safety assessments.
Fig.2 Major analytical services at Creative Biolabs.
We support your trials and validation through a comprehensive set of platforms for testing biologics. Our wide variety of technology platforms allows us to choose the right technology for your biomarker. Creative Biolabs also has extensive experience in applying these technologies in various matrices. No matter how complex the assay is, our team has the scientific and regulatory expertise to measure your biomarker and ensure the delivery of quality results on time.
Fig.3 Platforms at Creative Biolabs.
We Have Your Biomarker Assay Needs Covering
Our available services work perfectly as either a standalone or part of an end-to-end, well-integrated preclinical program. We can apply traditional and newer platforms as well as ultra-sensitive detection capabilities including single and multiplex analysis in various research fields. Creative Biolabs is proud to become a benchmark in the field and has a significant impact on our clients by using our expertise and state-of-the-art technology to advance/monitor drug development. With the addition of new technologies for biomarker analysis, we believe we will continue as a top-notch provider of biomarker assay services in the years to come. If you are interested in our biomarker analysis services, please feel free to contact us for more information.
Published Data
1. Label-Free LC-MS/MS Proteomic Analysis of Urine for Breast Cancer Biomarker Discovery
Fig.4 The interactive networks of breast cancer urinary proteins analyzed with LC-MS/MS.1
This work used unbiased, label-free LC-MS/MS-based proteomics to profile abundant proteins in breast cancer patient urine. Data analysis identified 59 urinary proteins significantly altered in breast cancer patients compared to controls (p<0.05, fold change >3). Among these, 36 proteins were stage-specific of breast cancer, with 24 upregulated and 12 downregulated. Amongst the 59 significant urinary proteins, 13 novel upregulated proteins were identified as potential biomarkers for breast cancer. Preliminary validation of three markers (ECM1, MAST4, and filaggrin) was conducted in breast cancer cell lines via Western blotting. The MAST4 biomarker was further validated in human breast cancer tissues and urine samples using immunohistochemistry and Western blotting, respectively.
2. Development of a Multiplex Immunoassay of Serum Biomarkers Aiding in Uveal Melanoma Detection
Fig.5 Workflow for magnetic bead-based multiplex immunoassay.2
Researchers developed a magnetic bead-based 7-plex immunoassay to evaluate serum biomarkers for early uveal melanoma (UM) detection. The assay targeted CEACAM-1, OPN, POSTN, MIA, MIC-1, SPON1, and HSP27, showing minimal cross-reactivity, recovery rates between 84% and 105%, and intra-assay/inter-assay precision ranging from 2.3% to 7.5% and 2.8% to 20.8%, respectively. Serum samples from 48 UM patients, comprising 14 with metastatic disease, 9 disease-free, and 25 with an unknown status, along with 36 healthy control individuals, were evaluated. Logistic regression analysis revealed a two-marker combination of HSP27 and OPN, which enhanced the discriminatory ability of individual biomarkers. This multiplex immunoassay provides reliable analytical performance for detecting UM through complementary serum biomarkers.
References
- Beretov, Julia, et al. "Proteomic analysis of urine to identify breast cancer biomarker candidates using a label-free LC-MS/MS approach." PloS one 10.11 (2015): e0141876. Distributed under Open Access license CC BY 4.0, without modification.
- Song, Jin, et al. "A multiplex immunoassay of serum biomarkers for the detection of uveal melanoma." Clinical Proteomics 16 (2019): 1-13. Distributed under Open Access license CC BY 4.0. The image was modified by extracting and using only part of the original image.
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