Biomarker is defined as “A biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biologic processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention” (Clin Pharmacol Ther. 69: 89-95, 2001) and in a broad sense it includes vital signs ordinary used in medical care, diagnostic test data (biochemical testing, blood testing, tumor marker), and diagnostic imaging data.
In the development of pharmaceuticals and functional foods, biomarkers are determined for various kinds of objectives such as pharmacometrics markers, safety/toxicity markers, and surrogate markers for evaluating end points. The objectives for the determination are varied, such as protein like cytokines or hormones, peptide, DNA, RNA and low molecule compounds.
Mediford Corporation offers contract services for biomarker analysis with biological samples derived from animals and humans. Regulation of studies can be set to GLP, Reliability standards, or non-GLP (no standards).
We can handle various kinds of matrices such as serum, plasma, urine, tissue, immune cells, culture supernatant and cerebrospinal fluid.
We will propose appropriate menu in accordance with the aim of analysis.
We conduct various biomarker analyses of biological specimens from humans or animals collected in non-clinical or clinical studies.
Appropriate analytical methods like LC-MS/MS or Ligand-Binding Assay (LBA) are selected according to the target biomarker.
We have experience in the determination of various hormones (pituitary/thyroid/adrenocortical hormone, etc.) and evaluation markers (renal function/inflammatory tumor/bone metabolic marker, etc.) in experimental animals. In response to each disease from clinical trials, we offer a variety of biomarker analyses for diabetes (GLP-1, GIP, DPP-IV activity), circulatory diseases (CETP concentration/activity, angiotensin), nephropathy (GST, KIM-1, FGF-23), and inflammation (cytokines/chemokines, lymphocyte subset). Please refer to “Menu of analytical items” for examples.
Highly sensitive and accurate analytical methods are required to correctly evaluate the fluctuations of biomarkers which are distributed in samples only in trace amounts.
Mediford Corporation has introduced high sensitivity instruments for LC-MS/MS and LBA, that enable us to meet various analytical needs.
In LC-MS/MS, we have introduced cutting-edge high sensitivity instruments in order to maintain sensitive and accurate analytical services.
In LBA, detection of very low concentration biomarkers at pg/mL to fg/mL levels is possible with the introduction of MESO QuickPlex SQ120 from Meso Scale Diagnostics（MSD） and SMCxPRO from Merck.
Electro-Chemi-Luminescence (ECL) is a method of detecting emission signals by electrochemical stimulation of agents labelled to detection antibodies. It provides low background level, wide dynamic range, and high sensitivity. It is compatible with a variety of sample types and can provide highly reliable data with excellent reproducibility.
Not only single item analysis, but multiplex analysis which can handle up to 10 items is also available. Please contact us for the lineup of biomarkers we can analyze.
This is a highly sensitive immunoassay platform which can detect very low concentration targets by antigen-antibody reaction and Single Molecular Counting (SMC) technology. In addition to dedicated kit products, modification of existing methods like ELISA for higher sensitivity is possible.
We offer analysis services for determination of multiple biomarkers simultaneously from small volume samples, tens of microliters of plasma or serum, etc.
Multiarray system by MSD can measure up to 10 markers simultaneously with a microplate-type device and utilize many kinds of high sensitivity/high precision kits. BioPlex Suspension Beads Array System consists of a bead-type device and it can measure up to 100 markers simultaneously. It is supported with various kits from Bio-Rad, Merck, and R&D Systems and has a diverse lineup based on animal species and target diseases.
In the research of biomarkers related to specific diseases or biomarkers related to signal transduction like cytokines/chemokines, it is useful to gain concentration information of those compounds all at once from a single sample to understand the interrelationship among them. And in a screening study that aims to discover or verify biomarkers, it is more efficient to evaluate concentrations and trends of multiple candidate markers at once and save much of the precious samples.
As for non-clinical studies, analysis of hormones/biomarkers from various experimental animals listed below is available. We have reference data of cycles of sex hormones, intra-day variance, and trends with week age.
Listed below is our experience in clinical studies.
This menu is only a sample of our services. We are able to provide other biomarker analysis services, so please feel free to consult us.