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Improving MedicinethroughInnovative Science www.geneuity.com
A division of MPLN is a full service, specialty clinical reference laboratory Founded in 1989 as one of the first molecular diagnostic          laboratories in the country Headquartered in Maryville, Tennessee with four laboratory operations in two states; currently 140 employees Privately held ‘C’ corporation with one owner and no other investors Financially stable with low D:E www.geneuity.com
Organizational Chart – January, 2010 www.geneuity.com
Geneuity Network of Services MPLN Molecular Diagnostics Laboratory TN MPLNFlow Cytometry Laboratory   Richmond, VA GeneuityClinical Research Services  Central Laboratory & High complexity Testing R & D AscendantMedical Laboratory Knoxville, TN Molecular Pathology Network Inc. (MPLN) AscendantMedical Laboratory  Memphis, TN Clinical Trials Protocol  Consultation Strategic Partnership & Alliance Program www.geneuity.com
Diagnostic & Clinical Trial Leadership Target Markets ,[object Object]
Dx. experience feeds into clinical trial business & vise versa
Specialize in molecular oncology, infectious diseases and IVDD
Open platforms to maximize assay repertoire & customization
MPLNetLIS & OpenClinica
Shared technical/scientific  resourceswww.geneuity.com
MPLN Diagnostic Lab Services Oncology (e.g., JAK 2, HER2, UroVysion) Pharmacogenetics, (e.g., KRAS, BRAF,  Warfarin) Infectious Disease (e.g., HCV, HPV, CTNG) Medical Genetics (e.g., CF, Thrombosis) Prenatal Care (e.g.,  CMV, AFP, FISH/Cyto) www.geneuity.com
Geneuity Clinical Research Services Experienced, Comprehensive Services: Preclinical – Phase IV Trial Testing Custom Assay Development , Method Transfer,  Analytical Validation IVD kit & Instrument Validation Advanced Molecular, Proteomic  & Cellular Testing – comprehensive test menu Routine Central Laboratory Testing www.geneuity.com
Geneuity: The AdvantageFlexible, Responsive, Reliable One specimen, multiple testing  options Molecular & clinical diagnostic expertise Protocol consultation 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  MDx (e.g., JAK2, HPV, BCR-ABL) Viral load testing, genotyping DNA sequencing  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
Proteomics – Multiplex Protein Analysis Flexible Platforms-multiplexing potential Commercial kits or custom design Custom mix of Individual analytes available Cytokines/ Chemokines/cell signaling arrays ELISA. Luminex. IHC, Flow cytometry www.geneuity.com
Luminex Analysis Based on Flow cytometry technology  Multiplexing available Protein or DNA analysis  Kits, custom mixing, or custom beads Some kits approved for diagnostics www.geneuity.com
Flow Cytometry Comprehensive ImmunoPhenotyping Characterize biomarker expression Establish pharmacodynamic  relationships Diagnostic testing for trial eligibility Detect and quantify cell lineage , low level expression, cell subtype and  #; Can detect Surface, intracellular, intranuclear markers; Experienced analytical validation of any marker Board Certified hematopathologists www.geneuity.com www.geneuity.com
Immunohistochemistry & Anatomic Pathology Localize Biomarkers at cellular and subcellular level Full service IHC with digital imaging available Validate new IHC markers Anatomic pathology services Board-certified anatomical, clinical and hematopathologists www.geneuity.com
CellSearch™ Diagnostics Detect Circulating Epithelial Cells Approved for Early Diagnosis of metastatic breast, colorectal and prostate cancer EpCAM+,(Fe) , CK+, CD45-, DAPI, count CTCs Sensitivity = 5 cells/ 7.5 mL sample CTC counts are prognostic for overall survival after treatment and a measure of drug effectiveness www.geneuity.com
CellSearch™ RUO Detect Circulating Endothelial Cells - Indication of blood vessel damage/formation CTC-biomarker itself; well suited for clinical trials, with levels early indicator of drug efficacy.   Make decisions earlier to progress to Phase III Second channel available for cell surface analysis of CTCs (Veridex-Her2 & EGFR) Profile kit for isolation of CTCs followed by protein or DNA/RNA analysis www.geneuity.com
Geneuity  Central Laboratory Services Microbiology Hematology  Serology Biochemistry Urinalysis Immunoassay www.geneuity.com

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Geneuity.Mpln.Overview

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

Hinweis der Redaktion

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