Geneuity Clinical Research Services

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

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Experienced, Dedicated and Reliable Services:

Geneuity: The AdvantageFlexible, Responsive, Reliable

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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)

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Advanced Molecular Technologies

Custom Pharmacogenomics:

DNA/RNA isolation

SNP analyses

Qualitative/quantitative RT-PCR

Multiplex PCR analysis

DNA sequencing

PET/CT molecular imaging

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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

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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

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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

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Microbiology

Hematology

Serology

Biochemistry

Urinalysis

Immunoassay

Geneuity Central Laboratory Services

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High Complexity Status - Testing Platform development in house

Protocol optimization

Beta-testing

Geneuity: IVD Kit Validation for FDA Approval

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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

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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

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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

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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 mobilertaylor@geneuity.com

www.geneuity.com