MPLN is a full-service clinical reference laboratory founded in 1989 specializing in molecular diagnostics, clinical trials support, and research services. It has four laboratory locations across two states with over 140 employees. MPLN offers a variety of molecular and clinical testing services including oncology, infectious disease, pharmacogenetics testing, and clinical trials support. It prides itself on being a flexible, responsive, and reliable partner for clinical testing and research.
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
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
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
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
Microspheres encoded with combinations of spectrally distinct fluorescent dyes to determine relative conc. of proteins or DNA molecules in same sample at same time.