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Improving Medicinethrough Innovative Science
www.geneuity.com
www.geneuity.com
A Complete Menu of Specialized Laboratory Testing Services
A division of
Founded in 1989
Geneuity Clinical Research 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
Experienced, Dedicated and Reliable Services:
Geneuity: The AdvantageFlexible, Responsive, Reliable
www.geneuity.com
Customized, Specialty testing; flexible platforms
Molecular & clinical diagnostic expertise
OpenClinica Secure data & customized reports
Specimen & patient resource
Bio-storage availability
Price competitive
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
Disease or system-specific
Flexible platforms
Custom assay design of Individual analytes available
Cytokines/ Chemokines/cell signaling protein arrays available
Multiplex Protein Assays
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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.comwww.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
Fluorescence in situ hybridization (FISH)
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Chromosomal location of specific DNA sequences
Validation and testing of novel FISH probes
Detection of chromosomal abnormalities
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
Microbiology
Hematology
Serology
Biochemistry
Urinalysis
Immunoassay
Geneuity Central Laboratory Services
www.geneuity.com
High Complexity Status - Testing Platform development in house
Protocol optimization
Beta-testing
Geneuity: IVD Kit Validation for FDA Approval
www.geneuity.com
ExperiencedRepresentative 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
OpenClinicaFDA-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 development•Biomarker selection• Scientific consultation• Logistics•Documentation
Protocol ConsultationProtocol
ConsultationAssay
DevelopmentAssay
DevelopmentSpecimen Handling
Specimen Handling TestingTesting Additional
Services Additional
ServicesBio-
informaticsBio-
informatics
•Custom assay design & development
•Platform selection•Protocol validation•Concordance
• Logistics•Documentedchain 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
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.
Quality Assurance
www.geneuity.com
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
Leading the Industry in Innovation
Thank you
For more information regarding capabilities, partnerships & pricing proposals contact:
Ranee Taylor, PhDDirector, Business Development865.380.2726 office865.621.9349 [email protected]
www.geneuity.com
