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SECURE


Secure and reliable information is vital in clinical trials and IVD research. At Geneuity, our laboratory information system provides secure specimen accessioning, data archival and customized reporting capabilities.

Our information technology and software design services include sophisticated data and facility security systems served by a dedicated backup power generation system.

QUALITY

The Quality Assurance Department ensures compliance to SOPs, GCP, GDP and GLP.

Geneuity is certified by the Clinical Laboratory Improvement Amendments (CLIA) ACT of 1988 for high complexity testing and accredited by the College of American Pathologists (CAP), and licensed by the states of Tennessee, New York, Maryland and Florida.

 





INTEGRATED ANALYSIS

clinical research services

Geneuity supplies an

array of tests and services to provide an integrated molecular approach

to meet all our clients' needs. Our scientists can provide customized design and optimization of study specific assays.

Geneuity offers technical and interpretive expertise in oncology, infectious diseases, medical genetics and clinical pathology. Board certified molecular, cytogenetic and hematopathology experts are available to assist in the development and review of study protocols.

Biomarker Analysis

  • Immunofluorescence
  • Flow Cytometry
  • Immunohistochemistry with virtual imaging
  • Cell proliferation
  • Immunomagnetic cell capture and fluorescence for circulating tumor cell detection (CellSearch™)
  • Cytogenetics and karyotyping
  • Multiplex quantitative cytokine and cell signaling detection

 

Molecular Analysis

  • Qualitative PCR and TMA
  • Quantitative Real-time PCR
  • Multiplex PCR and microarray analysis
  • Allelic and viral load testing
  • Genotyping
  • SNP/Point mutation characterization
  • Fluorescent DNA fragment analysis
  • Hybrid capture
  • Fluorescent microarrays (Luminex platform)
  • Fluorescent in situ hybridization
  • Capillary gel electrophoresis
  • DNA sequencing
  • Genome-wide gene expression microarrays and exon scanning
  • PET/CT nuclear imaging

 

Clinical Pathology

  • Biochemistry
  • Hematology
  • Immunoassays
  • Serum protein electrophoresis
  • Urinalysis
  • Toxicology/drug screening
  • Allergy blood testing

TECHNOLOGY PLATFORMS

Our platforms are available for custom assay design and validation for clinical research and IVD manufacturer assay validation. The following list is representative of our current platforms.

Strategic Specialization & Platforms


Cellular Platforms

  • 5 color FC500® Flow Cytometers
  • 4 color EPICS XL-MCL® Flow Cytometers
  • CellTracks® Analyzer
  • Zeiss MicroImaging for IHC
  • Dako Autostainer for IHC


    Molecular Platforms

  • ABI PRISM® 7900, 7500, 3100, 310
  • Gen-Probe TIGRIS® / DTS™
  • Luminex® 100™
  • Olympus Bioview Imaging System
  • Metafer 4 Imaging System
  • Roche TaqMan 48
  • Roche COBAS AMPLICOR
  • *Siemens PET/CT scanner

Clinical Platforms

  • Immulite 2000
  • Centaur Immunoassay
  • Advia 1650 Biochemistry
  • Advia 120S Hematology
  • Bayer Clinitek Urinalysis


*Application of in vivo quantitative imaging within clinical trials is now recognized as a powerful window into drug effectiveness and provides strong safety and efficacy evidence.