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Improving MedicinethroughInnovative Science www.geneuity.com
A Complete Menu of Specialized Laboratory Testing Services A division of www.geneuity.com Founded in 1989
Geneuity Clinical Research Services Experienced, Dedicated and Reliable Services: Preclinical – Phase IV Trial Testing Advanced Molecular & Proteomic Testing Custom Assay Development IVD kit & Instrument Validation Central Laboratory Testing Protocol Consultation www.geneuity.com
Geneuity: The AdvantageFlexible, Responsive, Reliable Customized, Specialty testing; flexible platforms Molecular & clinical diagnostic expertise OpenClinica Secure data & customized reports Specimen & patient resource Bio-storage availability Price competitive www.geneuity.com
Biomarker Analyses Proteomics Immunoassays Flow Cytometry IHC & Anatomic Pathology Routine Clinical testing & Microbiology Circulating Tumor Cell Detection (CellSearchTM) www.geneuity.com
Advanced Molecular Technologies Custom Pharmacogenomics: DNA/RNA isolation SNP analyses Qualitative/quantitative RT-PCR Multiplex PCR analysis DNA sequencing  PET/CT molecular imaging www.geneuity.com
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
Flow Cytometry Comprehensive ImmunoPhenotyping Characterize biomarker expression Establish pharmacodynamic & pharmacokinetic relationships Detect and quantify cell lineage Board Certified hematopathologists Detect low level expression www.geneuity.com www.geneuity.com
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
Fluorescencein situ hybridization (FISH) Chromosomal location of specific DNA sequences Validation and testing of novel FISH probes Detection of chromosomal abnormalities www.geneuity.com
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
Geneuity  Central Laboratory Services Microbiology Hematology  Serology Biochemistry Urinalysis Immunoassay www.geneuity.com
Geneuity:  IVD Kit Validation for FDA Approval High Complexity Status - Testing Platform development in house Protocol optimization Beta-testing www.geneuity.com
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
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
Protocol Consultation Assay Development Specimen Handling Testing       Additional      Services Bio-informatics ,[object Object]
Biomarker selection
Scientific consultation

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Geneuity Clinical Research Services

  • 2. A Complete Menu of Specialized Laboratory Testing Services A division of www.geneuity.com Founded in 1989
  • 3. Geneuity Clinical Research Services Experienced, Dedicated and Reliable Services: Preclinical – Phase IV Trial Testing Advanced Molecular & Proteomic Testing Custom Assay Development IVD kit & Instrument Validation Central Laboratory Testing Protocol Consultation www.geneuity.com
  • 4. Geneuity: The AdvantageFlexible, Responsive, Reliable Customized, Specialty testing; flexible platforms Molecular & clinical diagnostic expertise OpenClinica Secure data & customized reports Specimen & patient resource Bio-storage availability Price competitive www.geneuity.com
  • 5. Biomarker Analyses Proteomics Immunoassays Flow Cytometry IHC & Anatomic Pathology Routine Clinical testing & Microbiology Circulating Tumor Cell Detection (CellSearchTM) www.geneuity.com
  • 6. Advanced Molecular Technologies Custom Pharmacogenomics: DNA/RNA isolation SNP analyses Qualitative/quantitative RT-PCR Multiplex PCR analysis DNA sequencing PET/CT molecular imaging www.geneuity.com
  • 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
  • 8. Flow Cytometry Comprehensive ImmunoPhenotyping Characterize biomarker expression Establish pharmacodynamic & pharmacokinetic relationships Detect and quantify cell lineage Board Certified hematopathologists Detect low level expression www.geneuity.com 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
  • 12. Geneuity Central Laboratory Services Microbiology Hematology Serology Biochemistry Urinalysis Immunoassay 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
  • 16.
  • 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