Pathology and Biobanking

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Abstract The Pathology and Biobanking Core (PBC) has supported the efforts of the Baylor College of Medicine Breast SPORE for 26 years, offering comprehensive pathology services to SPORE investigators and others. All projects in this SPORE application propose the use of human biospecimens in assay development and for retrospective and/or prospective clinical trials, and this shared resource core is structured to meet the demands for high-quality, centralized banking and distribution of tissue specimens within this context. We have expertise and dedicated personnel for all routine histological studies, immunohistochemistry, immunofluorescence, tissue microarray preparation, and macro/micro-dissection techniques. Additionally, the Core supports advanced microscopy and digital imaging capability. All projects will also benefit from our recent expansion of state-of-the art molecular diagnostic platforms and high-complexity assay development, including quantitative PCR, microfluidics-based digital droplet PCR (ddPCR), next generation sequencing (NGS). The Core will provide the following services to projects and integration with other cores in this proposal: 1) a centralized resource to acquire, store, and utilize human biospecimens for cancer research; 2) To coordinate and manage the pathology activities of the SPORE, and ensure that Project Investigators have ready access to specialized pathology expertise and interpretation; and 3) to design and validate biomarker-based tests (genomic and/or proteomic) that support all project stages, including clinically-validated and reported assays for SPORE- based clinical trials. The SPORE benefits from integrated interactions between components, and this Core will work closely with other cores, particularly the Informatics and Statistics Core (ISC) for project design and correlative analyses. Further we will collaborate with the ISC to assist with selection and implementation of biospecimen repository, tracking and management software that spans all SPORE components. We will work with the Administration and Advocacy Core in management of laboratory resources and assist Career Development trainees with education in assay development and experimental analysis. The Core will assist proposed and funded Pilot Studies with exploratory assay design and technical validation support. The Pathology and Biobanking Core Laboratory is seeking both CLIA- and CAP-certification to meet Precision Medicine initiatives of this SPORE at Baylor College of Medicine.