The use of biochemical markers as surrogate endpoints for measuring the effects of investigational compounds and monitoring disease progression has increased significantly over the last decade.
Bioclinica Lab has extensive experience with efficacy biomarkers, predictive biomarkers, and safety biomarkers. We offer more than 70 biochemical assays performed with manual and/or automated methods and determine the most suitable method for each biomarker according to performance and test kits. Our facilities are equipped with state of the art robotics and a dedicated laboratory space for performing radioactive assays. Using Multiplex technology, we offer our clients the ability to monitor several biomarkers in parallel.
|Our biomarker assays include:|
|Radioimmunoassays (IRMA, RIACT)|
|Our comprehensive biomarker panel
spans many therapeutic areas including:
|Bone and Cartilage diseases|
|CNS diseases (Alzheimer's)|
|Inflammatory and Immunological diseases|
|Metabolic diseases (Diabetes)|
All Bioclinica Lab assays are validated and qualified in-house according to a rigorous evaluation process and current international guidelines. We can also perform assay validation of customer-selected biomarkers or adapt assays to special biological matrices (e.g. synovial fluid or BALF).
Bioclinica Lab validates each kit/method used for biomarker detection in a clinical study. Using assay validation, we objectively establish the reliability of a particular analytical method and ensure the accuracy and reliability of results.
A validation report summarizes the results of a test performance at Bioclinica Lab compared to manufacturer's data.
- assay procedures
- intra- and inter- assay variations, recovery, linearity and limits of detection
- biomarker stability in a specific matrix for storage conditions and freeze-thaw cycles
- expected values for population type (if data are available)
Prior to validation, we recommend a feasibility study to our clients for evaluating the potential of a method in a regulatory compliant environment. Bioclinica Lab will objectively qualify biomarker performance using a series of tests including dosage linearity and selectivity for a specific biomarker in a chosen matrix. At the end of a feasibility study, Bioclinica Lab will determine confidence in the chosen method and suitability for use in clinical trials.