Improving MedicinethroughInnovative Science<br />www.geneuity.com<br />
A Complete Menu of Specialized Laboratory Testing Services<br />A division of<br />www.geneuity.com<br />Founded in 1989<b...
Geneuity Clinical Research Services<br />Experienced, Dedicated and Reliable Services:<br />Preclinical – Phase IV Trial T...
Geneuity: The AdvantageFlexible, Responsive, Reliable<br />Customized, Specialty testing; flexible platforms<br />Molecula...
Biomarker Analyses<br />Proteomics<br />Immunoassays<br />Flow Cytometry<br />IHC & Anatomic Pathology<br />Routine Clinic...
Advanced Molecular Technologies<br />Custom Pharmacogenomics:<br />DNA/RNA isolation<br />SNP analyses<br />Qualitative/qu...
Multiplex Protein Assays<br />Disease or system-specific<br />Flexible platforms<br />Custom assay design of Individual an...
Flow Cytometry Comprehensive ImmunoPhenotyping<br />Characterize biomarker expression<br />Establish pharmacodynamic & pha...
Immunohistochemistry & Anatomic Pathology<br />Localize Biomarkers at cellular and subcellular level<br />Full service IHC...
Fluorescencein situ hybridization (FISH)<br />Chromosomal location of specific DNA sequences<br />Validation and testing o...
CellSearch™ Detection<br />Detect Circulating Epithelial and Endothelial Cells<br />Early Diagnosis of metastatic breast, ...
Geneuity <br />Central Laboratory Services<br />Microbiology<br />Hematology <br />Serology<br />Biochemistry<br />Urinaly...
Geneuity: <br />IVD Kit Validation for FDA Approval<br />High Complexity Status - Testing Platform development in house<br...
Experienced<br />Representative Case Studies:<br />Design & validate qPCR assays (e.g. JAK2)<br />Design & validate Lumine...
OpenClinica<br />FDA-endorsed open source electronic data capture (EDC) platform used in large scale, world-wide trials<br...
Protocol Consultation<br />Assay Development<br />Specimen Handling<br />Testing<br />      Additional <br />    Services<...
Biomarker selection
Scientific consultation
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Geneuity Clinical Research Services

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Geneuity Clinical Research Services

  1. 1. Improving MedicinethroughInnovative Science<br />www.geneuity.com<br />
  2. 2. A Complete Menu of Specialized Laboratory Testing Services<br />A division of<br />www.geneuity.com<br />Founded in 1989<br />
  3. 3. Geneuity Clinical Research Services<br />Experienced, Dedicated and Reliable Services:<br />Preclinical – Phase IV Trial Testing<br />Advanced Molecular & Proteomic Testing<br />Custom Assay Development<br />IVD kit & Instrument Validation<br />Central Laboratory Testing<br />Protocol Consultation<br />www.geneuity.com<br />
  4. 4. Geneuity: The AdvantageFlexible, Responsive, Reliable<br />Customized, Specialty testing; flexible platforms<br />Molecular & clinical diagnostic expertise<br />OpenClinica Secure data & customized reports<br />Specimen & patient resource<br />Bio-storage availability<br />Price competitive<br />www.geneuity.com<br />
  5. 5. Biomarker Analyses<br />Proteomics<br />Immunoassays<br />Flow Cytometry<br />IHC & Anatomic Pathology<br />Routine Clinical testing & Microbiology<br />Circulating Tumor Cell Detection (CellSearchTM)<br />www.geneuity.com<br />
  6. 6. Advanced Molecular Technologies<br />Custom Pharmacogenomics:<br />DNA/RNA isolation<br />SNP analyses<br />Qualitative/quantitative RT-PCR<br />Multiplex PCR analysis<br />DNA sequencing <br />PET/CT molecular imaging<br />www.geneuity.com<br />
  7. 7. Multiplex Protein Assays<br />Disease or system-specific<br />Flexible platforms<br />Custom assay design of Individual analytes available<br />Cytokines/ Chemokines/cell signaling protein arrays available<br />www.geneuity.com<br />
  8. 8. Flow Cytometry Comprehensive ImmunoPhenotyping<br />Characterize biomarker expression<br />Establish pharmacodynamic & pharmacokinetic relationships<br />Detect and quantify cell lineage<br />Board Certified hematopathologists<br />Detect low level expression<br />www.geneuity.com<br />www.geneuity.com<br />
  9. 9. Immunohistochemistry & Anatomic Pathology<br />Localize Biomarkers at cellular and subcellular level<br />Full service IHC with exclusive virtual imaging<br />Validate new IHC markers<br />Anatomic pathology services<br />Board-certified anatomical, clinical and hematopathologists<br />www.geneuity.com<br />
  10. 10. Fluorescencein situ hybridization (FISH)<br />Chromosomal location of specific DNA sequences<br />Validation and testing of novel FISH probes<br />Detection of chromosomal abnormalities<br />www.geneuity.com<br />
  11. 11. CellSearch™ Detection<br />Detect Circulating Epithelial and Endothelial Cells<br />Early Diagnosis of metastatic breast, colorectal and prostate cancer<br />Detection of blood vessel damage/formation<br />Extreme sensitivity to less than 5 cells/sample<br />www.geneuity.com<br />
  12. 12. Geneuity <br />Central Laboratory Services<br />Microbiology<br />Hematology <br />Serology<br />Biochemistry<br />Urinalysis<br />Immunoassay<br />www.geneuity.com<br />
  13. 13. Geneuity: <br />IVD Kit Validation for FDA Approval<br />High Complexity Status - Testing Platform development in house<br />Protocol optimization<br />Beta-testing<br />www.geneuity.com<br />
  14. 14. Experienced<br />Representative Case Studies:<br />Design & validate qPCR assays (e.g. JAK2)<br />Design & validate LuminexTM assay to measure drug induced blockage of protein:ligand binding<br />SNP genotyping assay design & validation<br />RT-PCR multiplex assay design & validation (e.g. HCV)<br />Test & validate companion diagnostic kits<br />Gene therapy custom PCR design for residual retroviral detection<br />Novel antibody validation for FISH and flow cytometry<br />www.geneuity.com<br />
  15. 15. OpenClinica<br />FDA-endorsed open source electronic data capture (EDC) platform used in large scale, world-wide trials<br />Secure, Web-based data management software with Graphical User Interface serves as an online, read-only laboratory notebook between Geneuity & client<br />Supports data submission & validation, data filtering & extraction<br />Supports study oversight, auditing and custom reporting<br />
  16. 16. Protocol Consultation<br />Assay Development<br />Specimen Handling<br />Testing<br /> Additional <br /> Services<br />Bio-informatics<br /><ul><li>Protocol development
  17. 17. Biomarker selection
  18. 18. Scientific consultation
  19. 19. Logistics
  20. 20. Documentation</li></ul>Custom assay design & development<br />Platform selection<br />Protocol validation<br />Concordance<br />Logistics<br />Documented<br />chain of handling<br />Specimen storage<br />High complexity analysis<br />Full test menu<br />CAP accredited<br />CLIA certified<br />GLP/GCP compliant<br />QA/QC program<br />Secure Data management<br />Data lock-out available<br />Custom LIS<br />Web enabled, custom reporting<br />Board-certified consultation & reporting available<br />Specimensourcing<br />SMO services<br />PET/CT imaging partner<br />Physician partners participation in clinical trials<br />MDx test commercialization<br />www.geneuity.com<br />
  21. 21. Leading the Industry in Innovation<br />Pinnacle Business Innovator Award 2008<br />National Diagnostic Marketing Award 2008<br />Pinnacle Business Excellence award 2007<br />National Diagnostic Marketing Award 2007<br />Fourth largest Molecular Diagnostic Laboratory in US, <br /> Washington G-2 reports, 2007<br />Roche Molecular Center of Excellence 2004<br />Quality Assurance<br />Accreditations & licenses:CLIA certified for high complexity, CAP accredited GLP, GCP, GDP compliant<br />Board certified experts: ABP in cytopathology, hematology, anatomic and clinical pathology<br />ACMG in cytogenetics, medical genetics and molecular genetics<br />Faculty appointments: Pathology, University of Tennessee Graduate School of Medicine. <br />www.geneuity.com<br />
  22. 22. Thank you<br />For more information regarding capabilities, partnerships & pricing proposals contact:<br />Ranee Taylor, PhD<br />Director, Business Development<br />865.380.2726 office<br />865.621.9349 mobile<br />rtaylor@geneuity.com<br />www.geneuity.com<br />

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