Pathology Lab

Pathology is integral to all pre-clinical studies performed to satisfy regulatory requirements and safety assessments. The pathological evaluation is one of the most crucial steps from which go/no go decisions are made.

The ESS pathology core is dedicated to:

• Commitment to scientific excellence
• Appreciation for client-specific issues
• Responsiveness and excellent turnaround time
• Exercise of independent judgment in order to accommodate the dynamic needs of the rapidly evolving biomedical community.

Experience

Our contract veterinary pathologist has 30 years expertise in comparative and anatomical pathology, and a 15+ year expertise in the pathology of implantable medical devices. He brings a very broad knowledge base of comparative species differences and gross pathology and histopathology in animal studies. The use of established evaluation criteria and exploitation of validated methods ensures high quality work in the complex analysis of the interaction between host tissue and device. Our pathology team has experience conducting necropsy's in all large animal species(sheep, pig, dog, nonhuman primate).

Service

The pathology core may collaborate directly with sponsors and investigators in developing study protocols and selecting appropriate methodologies. Therefore, the core can advise and contribute broadly to the many facets of research and development programs from the initiation of the study to its completion.

Pathologists and carefully trained necropsy technicians conduct on-site post mortem evaluations of animals used for device testing. On site location allows for timely conduct of explant retrieval of biomaterial/medical devices or tissue samples. Full necropsies put the pathologist in a direct position to evaluate not only the gross appearance of the tissues in contact with the device, but also to assess local or systemic effects that may be related to the device. Whole-body or organ perfusion techniques are daily routine and in place when required for studies having ultrastructural requirements.

Instant and appropriate specimen processing is further directed. The Pathology Core¿s capabilities include paraffin, plastic, and cryo-sectioning. Routine HE staining, a battery of histochemical special stains and a wide range of immunhistochemical markers are available. Ultrastructural studies may be performed on request. All services are rendered via on site laboratories or outside contractors.

Research is performed in full compliance with protocol and regulatory requirements and under constant review and implementation of applicable SOPs. In addition, ESS¿s independent Quality Assurance Unit performs in-progress audits of studies with GLP requirements.

Delivery

Necropsy, histology or pathology reports are individualized per client specifications and include animal demographics, descriptive narration, digital gross images and histology photomicrographs, tabulated data, diagnosis of lesions and discussion of significant findings. Pathology summaries with conclusions are provided for study reports; perspective is offered in terms of biological significance, and findings are extrapolated to the intended clinical indication.

Using modern photographic equipment, ESS pathologists and technicians have a unique commitment to excellence in photographic documentation of macroscopic and microscopic findings. Presentation of photographic findings may be in the form of kodachromes, glossy photos, digitized color prints or stored digital images.

Using a NIH Image Analysis Software, ESS Pathologists are in the position to measure tissue thickness (neointima, fibrous capsules), areas (lumens), or may quantify a cellular infiltrate (via immunocytochemistry).