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Welcome to the Pathogenesys service information page. We are the premier provider of Pathology Services. Our goal is to provide you reliable data and test results from our esoteric or molecular analytical efforts. Our quality control standards are high. Data integrity is maintained at the highest level through proper use and documentation of personnel training and qualification, equipment qualification and monitoring, quality assurance auditing, and adherence to all Good Laboratory and Good Clinical Practice Standards. Delivery of data on the client’s time schedule is of paramount importance to us. Below is a short list of the services we offer: Semi-Quantitative Immunohistochemistry - Pathogenesys offers standard practice and innovative immunohistochemical staining and analysis of paraffin-embedded or non-fixed tissue sections with analysis by a Board-Certified Pathologist. This service involves comprehensive analysis and data capture that includes over 30 morphologic or histochemical features to maximize ultimate bioinformatic analysis. This service can also be complemented through the appropriate application of digital image analysis (see below). Rare Event Analysis - Pathogenesys offers an innovative, fluorescence-based approach for the identification and quantification of rare tumor cells in blood or tissues. Analysis is performed by an experienced Board-Certified Pathologist. This experimental approach can help segregate Human Subjects prior to or during the conduct of clinical trials. Cancer Biomarker Analysis - Pathogenesys offers the analysis in serum or plasma of several tumor biomarkers by standard ELISA. Fluorescence In Situ Hybridization - Pathogenesys offers standard practice and innovative fluorescence in situ hybridization staining and analysis of paraffin-embedded or non-fixed tissue sections by an experienced Board-Certified Pathologist. Molecular Testing - Pathogenesys will soon be offering molecular tests for the analysis of Microsatellite Instability, loss of heterozygosity for several genetic loci, and limited gene mutational analysis. Image Analysis - COMING SOON! Pathogenesys is in the process of acquiring a new image analysis platform that offers the advantage of analyzing an image of the entire tissue section as opposed to the fractional analysis of “hot spots”. Customizable solutions and client access to images through a web-based portal will be available. Oncology Clinical Trials Biomarker Algorithms - The discovery and implementation of useful biomarker algorithms that will facilitate efficacious trials is possible. We have been successful in the analysis of “failed” trials using Discriminant Analysis and other statistical approaches to identify combinations of biomarkers that will predict oncology drug responses. If proven useful, these algorithms could be used to screen for responsive patients or monitor patients on trials and lead to a more successful clinical trial. Our typical approach is to reanalyze and/or stain remnant paraffin section for Immunohistochemical markers and capture data representing over 16 morphologic features of the patient’s tumor. These variables can be analyzed relative to outcomes data to find the best combination of biomarkers to use in future trials. Depending on the number of cases and previous responders, these efforts can be segregated into discovery and validation phases to provide better utility of the algorithms. Prices will be dependent upon volume and complexity of testing. For more information or to schedule a complimentary consultation, please contact us either via e-mail at info@pathogenesys.com. You may also call us at 949-258-0318 from 8 AM to 5 PM Pacific Standard Time. We look forward to serving you.
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