7. Multiplex Protein Assays Disease or system-specific Flexible platforms Custom assay design of Individual analytes available Cytokines/ Chemokines/cell signaling protein arrays available www.geneuity.com
9. Immunohistochemistry & Anatomic Pathology Localize Biomarkers at cellular and subcellular level Full service IHC with exclusive virtual imaging Validate new IHC markers Anatomic pathology services Board-certified anatomical, clinical and hematopathologists www.geneuity.com
10. Fluorescencein situ hybridization (FISH) Chromosomal location of specific DNA sequences Validation and testing of novel FISH probes Detection of chromosomal abnormalities www.geneuity.com
11. CellSearch™ Detection Detect Circulating Epithelial and Endothelial Cells Early Diagnosis of metastatic breast, colorectal and prostate cancer Detection of blood vessel damage/formation Extreme sensitivity to less than 5 cells/sample www.geneuity.com
13. Geneuity: IVD Kit Validation for FDA Approval High Complexity Status - Testing Platform development in house Protocol optimization Beta-testing www.geneuity.com
14. Experienced Representative Case Studies: Design & validate qPCR assays (e.g. JAK2) Design & validate LuminexTM assay to measure drug induced blockage of protein:ligand binding SNP genotyping assay design & validation RT-PCR multiplex assay design & validation (e.g. HCV) Test & validate companion diagnostic kits Gene therapy custom PCR design for residual retroviral detection Novel antibody validation for FISH and flow cytometry www.geneuity.com
15. OpenClinica FDA-endorsed open source electronic data capture (EDC) platform used in large scale, world-wide trials Secure, Web-based data management software with Graphical User Interface serves as an online, read-only laboratory notebook between Geneuity & client Supports data submission & validation, data filtering & extraction Supports study oversight, auditing and custom reporting
20. DocumentationCustom assay design & development Platform selection Protocol validation Concordance Logistics Documented chain of handling Specimen storage High complexity analysis Full test menu CAP accredited CLIA certified GLP/GCP compliant QA/QC program Secure Data management Data lock-out available Custom LIS Web enabled, custom reporting Board-certified consultation & reporting available Specimensourcing SMO services PET/CT imaging partner Physician partners participation in clinical trials MDx test commercialization www.geneuity.com
21. Leading the Industry in Innovation Pinnacle Business Innovator Award 2008 National Diagnostic Marketing Award 2008 Pinnacle Business Excellence award 2007 National Diagnostic Marketing Award 2007 Fourth largest Molecular Diagnostic Laboratory in US, Washington G-2 reports, 2007 Roche Molecular Center of Excellence 2004 Quality Assurance Accreditations & licenses:CLIA certified for high complexity, CAP accredited GLP, GCP, GDP compliant Board certified experts: ABP in cytopathology, hematology, anatomic and clinical pathology ACMG in cytogenetics, medical genetics and molecular genetics Faculty appointments: Pathology, University of Tennessee Graduate School of Medicine. www.geneuity.com
22. Thank you For more information regarding capabilities, partnerships & pricing proposals contact: Ranee Taylor, PhD Director, Business Development 865.380.2726 office 865.621.9349 mobile rtaylor@geneuity.com www.geneuity.com