Our laboratory is focused on the assessment of disease-associated changes in animal or patient tissue, with a focus on structural abnormalities (pathology) and the expression of proteins related to the specific disease. While we have considerable flexibility in the development of new testing strategies for specific disorders or situations, our most commonly used services are listed below.
Specialized Tissue Histology Staining
In addition to the standard hematoxylin and eosin (H&E) stain used for tissue evaluation by pathologists, there are numerous specialized staining techniques that can highlight specific features of interest in the tissue. Our laboratory is highly experienced in specialized histological staining and we have an excellent track record of rapidly establishing new techniques based on evolving needs of our clients.
Quantification of Protein Expression by Western Blot
Western blot is a technique used to visualize a protein of interest according to its molecular weight and its recognition by an antibody specific for that protein. Western blot assays can be designed to offer quantitative information on protein expression, and we have specific experience in designing and performing these assays in a way that adheres to FDA guidance.
Assessment of Tissue Histology
Many diseases produce characteristic structural changes in tissue that may vary over time or between subjects. As Dr. Lawlor is a board-certified anatomic pathologist and neuropathologist with an international reputation as an expert in muscle pathology, we are well-suited to the analysis of diseased and treated tissue and the development of analytical and quantification strategies that would be useful in a specific situation. Additionally, we have a vast network of collaborators that specialize in other tissue types and other disease states, which allows for the consultation of world-class experts for issues that are outside of our areas of expertise.
Advisory Services and Operational Support
We have experience in key areas of technical design, clinical trial planning and operations, and data presentation and analysis. Our diverse scientific background allows us to actively participate as needed in preclinical and clinical trial study planning, training, and execution within our areas of expertise, and these services can be highly valuable in maximizing the speed of study completion and clinical trial translation. As noted above, this can also include working with our professional network to leverage the expertise of academic specialists who may not be accustomed to working with industry partners.
Detection and Localization of Protein Expression Using Immunofluorescence and Immunohistochemistry
Many genetic disorders (and most of the disorders for which gene therapy is being tested) are related to the loss or marked deficiency of a single key protein. Antibodies that detect a protein of interest can be used to demonstrate its presence and location, which is a key element of therapeutic efficacy in the setting of protein or gene replacement. We have considerable expertise in the developing, imaging, and interpreting these sorts of assays in the context of disease and therapeutic efficacy characterization.