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  • Microspheres encoded with combinations of spectrally distinct fluorescent dyes to determine relative conc. of proteins or DNA molecules in same sample at same time.
  • Geneuity.Mpln.Overview

    1. 1. Improving MedicinethroughInnovative Science<br /><br />
    2. 2. A division of<br />MPLN is a full service, specialty clinical reference laboratory<br />Founded in 1989 as one of the first molecular diagnostic laboratories in the country<br />Headquartered in Maryville, Tennessee with four laboratory operations in two states; currently 140 employees<br />Privately held ‘C’ corporation with one owner and no other investors<br />Financially stable with low D:E<br /><br />
    3. 3. Organizational Chart – January, 2010<br /><br />
    4. 4. Geneuity Network of Services<br />MPLN Molecular Diagnostics Laboratory TN<br />MPLNFlow Cytometry Laboratory <br />Richmond, VA<br />GeneuityClinical Research Services <br />Central Laboratory & High complexity Testing<br />R & D<br />AscendantMedical Laboratory<br />Knoxville, TN<br />Molecular Pathology Network Inc. (MPLN)<br />AscendantMedical Laboratory <br />Memphis, TN<br />Clinical Trials Protocol Consultation<br />Strategic Partnership & Alliance Program<br /><br />
    5. 5. Diagnostic & Clinical Trial Leadership<br />Target Markets<br /><ul><li>Consistent growth >20% / yr
    6. 6. Dx. experience feeds into clinical trial business & vise versa
    7. 7. Specialize in molecular oncology, infectious diseases and IVDD
    8. 8. Open platforms to maximize assay repertoire & customization
    9. 9. MPLNetLIS & OpenClinica
    10. 10. Shared technical/scientific resources</li></ul><br />
    11. 11. MPLN Diagnostic Lab Services<br />Oncology (e.g., JAK 2, HER2, UroVysion)<br />Pharmacogenetics, (e.g., KRAS, BRAF, Warfarin)<br />Infectious Disease (e.g., HCV, HPV, CTNG)<br />Medical Genetics (e.g., CF, Thrombosis)<br />Prenatal Care (e.g., CMV, AFP, FISH/Cyto)<br /><br />
    12. 12. Geneuity Clinical Research Services<br />Experienced, Comprehensive Services:<br />Preclinical – Phase IV Trial Testing<br />Custom Assay Development , Method Transfer, Analytical Validation<br />IVD kit & Instrument Validation<br />Advanced Molecular, Proteomic & Cellular Testing – comprehensive test menu<br />Routine Central Laboratory Testing<br /><br />
    13. 13. Geneuity: The AdvantageFlexible, Responsive, Reliable<br />One specimen, multiple testing options<br />Molecular & clinical diagnostic expertise<br />Protocol consultation<br />Secure data & customized reports<br />Specimen & patient resource<br />Bio-storage availability<br />Price competitive<br /><br />
    14. 14. 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 /><br />
    15. 15. Advanced Molecular Technologies<br />Custom Pharmacogenomics:<br />DNA/RNA isolation<br />SNP analyses<br />Qualitative/quantitative RT-PCR <br />MDx (e.g., JAK2, HPV, BCR-ABL)<br />Viral load testing, genotyping<br />DNA sequencing <br /><br />
    16. 16. 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 /><br />
    17. 17. Proteomics – Multiplex Protein Analysis<br />Flexible Platforms-multiplexing potential<br />Commercial kits or custom design<br />Custom mix of Individual analytes available<br />Cytokines/ Chemokines/cell signaling arrays<br />ELISA. Luminex. IHC, Flow cytometry<br /><br />
    18. 18. Luminex Analysis<br />Based on Flow cytometry technology <br />Multiplexing available<br />Protein or DNA analysis <br />Kits, custom mixing, or custom beads<br />Some kits approved for diagnostics<br /><br />
    19. 19. Flow Cytometry Comprehensive ImmunoPhenotyping<br />Characterize biomarker expression<br />Establish pharmacodynamic relationships<br />Diagnostic testing for trial eligibility<br />Detect and quantify cell lineage , low level expression, cell subtype and #; Can detect<br />Surface, intracellular, intranuclear markers; Experienced analytical validation of any marker<br />Board Certified hematopathologists<br /><br /><br />
    20. 20. Immunohistochemistry & Anatomic Pathology<br />Localize Biomarkers at cellular and subcellular level<br />Full service IHC with digital imaging available<br />Validate new IHC markers<br />Anatomic pathology services<br />Board-certified anatomical, clinical and hematopathologists<br /><br />
    21. 21. CellSearch™ Diagnostics<br />Detect Circulating Epithelial Cells<br />Approved for Early Diagnosis of metastatic breast, colorectal and prostate cancer<br />EpCAM+,(Fe) , CK+, CD45-, DAPI, count CTCs<br />Sensitivity = 5 cells/ 7.5 mL sample<br />CTC counts are prognostic for overall survival after treatment and a measure of drug effectiveness<br /><br />
    22. 22. CellSearch™ RUO<br />Detect Circulating Endothelial Cells - Indication of blood vessel damage/formation<br />CTC-biomarker itself; well suited for clinical trials, with levels early indicator of drug efficacy. <br />Make decisions earlier to progress to Phase III<br />Second channel available for cell surface analysis of CTCs (Veridex-Her2 & EGFR)<br />Profile kit for isolation of CTCs followed by protein or DNA/RNA analysis<br /><br />
    23. 23. Geneuity <br />Central Laboratory Services<br />Microbiology<br />Hematology <br />Serology<br />Biochemistry<br />Urinalysis<br />Immunoassay<br /><br />
    24. 24. Geneuity: <br />IVD Kit Validation for FDA Approval<br />High Complexity Status - Testing Platform development in house<br />Protocol optimization<br />Beta-testing<br />Diagnostic kit validation<br /><br />
    25. 25. 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 /><br />
    26. 26. Protocol Consultation<br />Assay Development<br />Specimen Handling<br />Testing<br /> Additional <br /> Services<br />Bio-informatics<br /><ul><li>Protocol development
    27. 27. Biomarker selection
    28. 28. Scientific consultation
    29. 29. Cost savings
    30. 30. Specimen conservation</li></ul>Custom assay design & development<br />Platform selection<br />Protocol validation<br />Method transfer & validation<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 />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 />Kit building services<br />Physician partners participation in clinical trials<br />MDx test commercialization<br />CRO partners<br /><br />
    31. 31. 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<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 /><br />
    32. 32. 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 /><br /><br />