Biomarker Services

Biomarkers are measurements of analytes in biological fluids and tissues that inform the investigator on the effect a drug has on a biological system and often are used to identify the correct patient subset to dose with a new therapeutic entity. KCAS has a large toolbox we can use to meet our clients’ biomarker needs.

.

Colorimetric analysis is a method of determining the concentration of a chemical element or chemical compound in a solution with the aid of a colorizing reagent. It is applicable to both organic compo. . .

.

Methods transferred into a new laboratory need to be re-established for regulatory compliance.  The extent to which an assay has to be re-validated varies, however, most methods necessitate full valid. . .

.

Since 2006, the KCAS has provided analytical support to companies developing treatments for menorrhagia (heavy menstrual bleeding), using the alkaline hematin assay.  Clinical trials for drug therapie. . .

.

Regulated clinical bioanalysis is a key focus at KCAS. Our data has been used in the approval of over 300 drugs over our 40 years of operation.

.

Flow cytometry is a technique used to detect and measure physical and chemical characteristics of a population of cells or particles. Tens of thousands of cells can be quickly examined and the data ga. . .

.

Fluorescence is used mainly for measuring compounds in solution, or in the case of flow cytometry, both on the cell surface & intracellularly. In fluorescence testing, both an excitation spectrum (the. . .

.

Luminescence immunoassays use the low-temperature emission of light (as by a chemical or physiological process) and are a variation of the standard ELISA assay. There are many types of luminescence as. . .

.

At KCAS, methods are developed with a fit-for-purpose design in mind, based on our Client’s needs. This can range from developing an assay in support of a proof-of-concept to a GLP-compliant investiga. . .

.

A fit-for-purpose approach is used by KCAS in method qualifications. Each method is designed to achieve not only a client’s objectives but budgetary constraints.

.

KCAS has extensive experience in validating methods in a wide range of bioanalytical platforms.  Our methods are designed to meet regulatory compliance with FDA, EMA, Health Canada and can meet guidel. . .

.

Multi-plex analysis of biomarkers is a powerful tool for screening of many analytes in a small volume of sample. Biomarkers serve as alternatives for assessing the functionality of therapeutics, mecha. . .

.

Regulated clinical bioanalysis is a key focus at KCAS, supporting both human and animal health programs.

.

Non-clinical (or often referred to as preclinical studies) non GLP samples are often used for biomarker and pd (pharmacodynamics) assessments for drug development. In the case of ex vivo therapies and. . .

.

Biomarkers come in many flavors and can be used as alternatives for assessing the functionality of therapeutics, mechanisms of action, predicting efficacy, monitoring toxicity, and stratification of p. . .

.

Time resolved fluorescence (TRF) relies on the use of very specific fluorescent molecules called lanthanides. These fluorescent molecules have the unusual property of emitting over long periods of tim. . .