R & D Services

PhenoPath’s R&D services include optimization and validation of immunohistochemistry (IHC), 10-color flow cytometry, fluorescence in situ hybridization (FISH), polymerase chain reaction (PCR), RNA/DNA ISH, immunofluorescence (IF) and specialty pathology assays for use in biomarker discovery, drug development, diagnosis and clinical trial applications.

Human, animal, xenografts, and patient-derived xenografts are commonly used in our clinical studies. PhenoPath provides histology services for FFPE and frozen tissue, cell pellet and tissue microarray preparation, and special stains.

PhenoPath has developed and validated over 800 IHC assays in its clinical and CRO settings. Other validated assays include RNAScope, 10-color flow cytometry, FISH, DNA-based PCR, Real-Time-PCR, immunofluorescence, and cytogenetics.

PhenoPath pathologists, scientists, project managers, and all PhenoPath staff strive to create an environment of collaboration with our clients. Teleconferences or webinars with PhenoPath’s scientific team are available to optimize information exchange. 

  • Testing Capabilities

    PhenoPath offers an extensive array of diagnostic assays including over 250 IHC antibodies validated in our clinical laboratory, an additional 100+ antibodies available in our research laboratory, over 100 flow cytometry antibodies, and a broad menu of FISH, PCR, cytogenetics and IF assays. Antibody targets include tissue-specific markers, tumor prognostic and predictive markers, surrogate markers of chromosomal translocations, and a broad range of esoteric antigens.

    PhenoPath utilizes advanced analytic instrumentation and internally developed information management technology to ensure the highest quality results, rapid test turnaround, and streamlined data transfer.

    Instrument/platform Methodology
    MetaSystems Metafer 4 FISH, Cytogenetics
    Beckman Coulter GalliosTM 10-Color Flow Cytometry
    Bio-Rad CFX96 PCR
    Roche cobas z 480 PCR
    Qiagen Rotor-Gene Q PCR

     

    Instrument/platform Methodology
    Dako Autostainer Link 48 IHC
    Dako Autostainer - other IHC
    Leica-BOND-MAX IHC, RNA ISH
    Aperio whole slide imaging IHC
    PerkinElmer Nuance/inForm Multispectral Imaging IHC, IF

    Additional technologies may be available; please inquire.

  • Method Development

    PhenoPath provides assay feasibility, optimization and validation services, including the selection of appropriate reagents, positive and negative controls, and appropriate tissues. Validation protocols include testing for specificity, sensitivity and reproducibility. PhenoPath is experienced in technology transfers of client-validated procedures. At the culmination of client-specific validation activities, PhenoPath provides the client with a comprehensive validation report upon request.

    PhenoPath’s team of pathologists, scientists, technicians, and project managers will help to research, design, and manage your project. PhenoPath’s experience with a wide variety of tissue types, methodologies and technologies provides a solid background for developing, validating and implementing each project.

    • A comprehensive panel of specimens (including abnormal and normal samples) are tested for sensitivity, specificity, and reproducibility
    • Controls and/or tissues are tested with alternative technology, when appropriate
    • Technology transfers include development of detailed procedures and creation of project-specific SOPs, if applicable
    • Test validation report provided

     

    Method Development (IHC):

    • Antibodies are carefully selected and methods developed
    • Antigen retrieval methods, antibody titer and detection systems are optimized
    • Antibodies can be tested on whole tissue sections, tissue microarrays, cell culture pellets, or xenografts
    • Antibody must stain tissue of interest, show no staining on negative controls, and exhibit the expected pattern of
    • cellular localization to satisfy PhenoPath’s screening criteria for acceptance

     

    Method Development (10-color flow cytometry):

    • Antibodies are carefully selected and titered
    • Up to 10-color custom assays may be designed for surface or intracellular antigens
    • Internal positive and negative control populations are generally used, but if not available, isotype-matched controls can be used 

Research & Development (Flyer)

PhenoPath, PLLC

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