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

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  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.