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Target Validation, Biomarker Validation, and Safety

Effective validation of therapeutic targets and biomarkers

Precision for Medicine, with a specific focus on histopathology and access to diverse biospecimens, provides a range of human tissue–based research services from the preclinical to clinical stages of development. We specialize in various programs involving small molecule, large molecule, and advanced therapeutics (gene and cell therapies). Our expertise in genomics and cell biology supports you in understanding target expression and localization, determining tumor biology and cellular interplay, and characterizing novel therapeutic entities.

Precision’s technologies providing biomarker and safety insight

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    Target Expression

    Using a proprietary qRT-PCR-based platform, whole body target expression data supports target validation, drug repurposing, evaluation of potential clinical safety concerns, and validation of animal models.
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    Cell-Based Assays

    Developing and qualifying 2D and 3D human in vitro cell-based models, using a broad range of human primary cell types. These models are further utilized in bioassays, with the analysis enabling a variety of endpoints.
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    Fluorescence In Situ Hybridization (FISH)/ISH

    Development of multiplex FISH/ISH assays to detect abnormalities in a range of tissues, including hematological and solid organ tumors.
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    Multiplex immunofluorescence (mIF)

    Automated multiplex immunofluorescence services that enable quantitative visualization of up to 9 markers in tissue and liquid biopsies.
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    tissue-slide

    lmmunohistochemistry (IHC)

    End-to-end IHC solutions including kitting, sample logistics, staining via all major platforms, and in-house pathology services.
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    tissue

    Tissue Biospecimens

    Thousands of IRB-approved, clinically annotated biospecimens, including samples characterized via next-generation sequencing (NGS), are available to help researchers optimize biomarker and diagnostic development. These are ready to ship the same day to your lab.
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Histopathology labs supporting beyond target and biomarker validation

Precision’s histopathology labs offer comprehensive services for target and biomarker validation. Our team of board-certified pathologists specialize in various areas of clinical research, including companion diagnostics development, and in vitro diagnostics (IVD) development.

  • iStock-1370585977

    Winston-Salem, North Carolina, US

    IHC/mIF Stainers & Scanners

    • Dako Autostainer Link 48
    • Dako PT Link
    • Leica Bond II
    • Ventana BenchMark ULTRA
    • Aperio GT 450
    • 3DHISTECH


    Certifications

    • CAP/CLIA
    • ISO 9001:2005
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    Houston, Texas, US

    IHC/mIF Stainers & Scanners

    • Leica Bond RX
    • Akoya Vectra Polaris
    • Aperio GT 450
    • InForm / HALO AP
    • Halo/AI


    Certifications

    • CLIA
    • GxP
  • iStock-980627542

    Royston, UK

    IHC/mIF Stainers & Scanners

    • Leica Bond RX
    • Dako Autostainer + PT Link
    • Ventana Discovery ULTRA 
    • Aperio AT2
    • Akoya Vectra Polaris
    • InForm / HALO AP


    Certifications

    • GLP
    • GCLP

Journey of a
Therapeutic Antibody:
From Preclinical to
Clinical Proof of Concept

Gain comprehensive insights into the process of developing therapeutic antibodies from discovery to clinical success.

eBook

Journey of a Therapeutic Antibody: Preclinical to Clinical Proof of Concept

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Journey of a Therapeutic Antibody: Preclinical to Clinical Proof of Concept

Approaches for target and biomarker validation, and for therapeutic characterization

Precision’s target and biomarker validation and safety services include consultative study design and assay development, analysis and interpretation of data, and data reporting.

target validation vert-1

Explore Precision’s other specialty assay areas

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    Immune-monitoring

    Immune Monitoring

    Leverage sophisticated immune monitoring approaches, including flow cytometry, Epiontis ID® immune cell phenotyping, and cytokine profiling, to characterize the immune cells in your samples and understand their impact on patient biology.

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    Bioanalytical

    Bioanalytical Testing

    At Precision, we understand the complexities of immunogenicity testing and other bioanalytical methods, with a leadership team that continues to shape and inform regulatory guidance. 

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    Tissue Biopsy Analysis

    At Precision for Medicine, we’re committed to delivering gold-standard tissue sourcing, processing, and analysis services.

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Discover the Precision blog

Read our blog to gain more insights and discover work that Precision has supported.

Read: Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

Translational Research - Regulatory - Assays - Gene Therapies

Gene Therapy Assays: Regulatory Compliance with Unified Immunogenicity

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778875, hs_child_table_id=0, hs_updated_at=1716454216458, hs_published_at=1739807653319, description=Pharma industry veteran and expert at biomarker-driven clinical trial design and execution. Leader of biomarker and drug development programs for pharmaceutical and diagnostics companies, as well as the National Institutes of Health. Spearheaded the discovery of pharmacodynamic biomarkers and novel targets for inflammatory disease therapy., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Deb%20Phippard.webp',altText='Deb Phippard',fileId=165892372605}, linkedin=https://www.linkedin.com/in/deb-phippard-103b54, team=[{id=163072475007, name='Precision for Medicine Leadership'}], hs_name=, hs_path=, lastname=Phippard, PhD, hs_initial_published_at=1716212769184, hs_created_at=1709645745106, hs_is_edited=false, hs_deleted_at=0, name=Deborah, job= Chief Scientific Officer, slug=deborah-phippard, email=, hs_updated_by_user_id=51739740}, second={hs_id=159488778840, hs_child_table_id=0, hs_updated_at=1716132440837, hs_published_at=1739807653319, description=Maham Ansari, MS, RAC is a Senior Director, IVD Regulatory Affairs. Her focus is on companion diagnostic co-development programs, where she leverages her regulatory expertise to secure approvals in the US, Europe and beyond for companion diagnostics with a specific focus on gene therapy. She brings more than 16 years of global regulatory leadership experience in the medical device and in vitro diagnostics industry, spanning major multinationals to small start-ups, including full life cycle management across all stages of product development, execution of global regulatory strategies, and post-market surveillance.sh, avatar=Image{width=710,height=710,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Maham_Ansari.png',altText='Maham_Ansari',fileId=167373022876}, linkedin=https://www.linkedin.com/in/maham-ansari-ms-rac-6a735739, hs_name=, hs_path=, lastname=Ansari, hs_initial_published_at=1716212769184, hs_created_at=1709645745071, hs_is_edited=false, hs_deleted_at=0, name=Maham, job=, slug=maham-ansari, email=, hs_updated_by_user_id=51739740}, third={}})
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    Deborah P.

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    Maham A.

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Read: Optimizing Immunohistochemistry Validation and Regulatory Strategies Optimizing Immunohistochemistry Validation and Regulatory Strategies

Translational Research - Biomarkers - Assays

Optimizing Immunohistochemistry Validation and Regulatory Strategies

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778874, hs_child_table_id=0, hs_updated_at=1714461729999, hs_published_at=1739807653319, description=Kennon Daniels is a scientific and regulatory in vitro diagnostic authority, specializing in the development of US regulatory strategies and FDA marketing submissions for IVD assays and instruments. Her expertise spans all aspects of product development, analytical and clinical trial protocol designs, Q-Submissions, IDEs, de novos, 510(k)s, and pre-market approval platforms., avatar=Image{width=576,height=576,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/PfM%20Website/Headshots/Headshots%20no%20background/Kennon%20Daniels.webp',altText='Kennon Daniels',fileId=165893120790}, linkedin=https://www.linkedin.com/in/kennon-daniels-ph-d-84a90b6, hs_name=, hs_path=, lastname=Daniels, hs_initial_published_at=1716212769184, hs_created_at=1709645745105, hs_is_edited=false, hs_deleted_at=0, name=Kennon, job=, slug=kennon-daniels, email=, hs_updated_by_user_id=51739740}, second={hs_id=182710436924, hs_child_table_id=0, hs_updated_at=1731419754428, hs_published_at=1739807653319, description=Christie Bongel, MS, CT(ASCP), brings nearly two decades of experience in both research and clinical medicine. As the site director for Precision for Medicine’s IHC Center of Excellence in North Carolina, she excels in managing scientific operations and collaborating with clients. Christie is skilled in cytology, laboratory medicine, and molecular diagnostics. Her role focuses on building an energized team dedicated to delivering life-changing outcomes for patients. Christie earned her MS in Applied Biotechnology and is an ASCP certified cytotechnologist., avatar=Image{width=260,height=260,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Christie%20Bongel_Square_260px.jpg',altText='Christie Bongel_Square_260px',fileId=178044303113}, lastname= Bongel, hs_initial_published_at=1731517828480, hs_created_by_user_id=28386183, hs_created_at=1731419696820, hs_is_edited=false, hs_deleted_at=0, name=Christie, job=Site Director - Histology, slug=christie-bongel, hs_updated_by_user_id=51739740}, third={}})
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    Kennon D.

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    Christie .

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Read: Women Leaders Share Raw Truths About Leadership in Life Sciences Women Leaders Share Raw Truths About Leadership in Life Sciences

Clinical Trials - Translational Research

Women Leaders Share Raw Truths About Leadership in Life Sciences

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    has not third author: true, (SizeLimitingPyMap: {main={hs_id=159488778858, hs_child_table_id=0, hs_updated_at=1736540179119, hs_published_at=1739807653319, description=Rob Maiale is an innovative marketing leader and creative technologist who transforms complex healthcare challenges into meaningful, impactful stories. With over 15 years of experience across clinical and translational research, patient education, pharmaceuticals, and diagnostics, he merges cutting-edge technology with inspired storytelling to build award-winning brand narratives. At Precision, Rob collaborates with leading experts to translate deep scientific expertise into accessible, engaging, and culturally resonant content—connecting audiences to the future of life-changing research., avatar=Image{width=400,height=400,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/Rob%20Maiale.jpg',altText='Rob Maiale',fileId=184765575245}, linkedin=https://www.linkedin.com/in/rob-maiale/, hs_name=, hs_path=, lastname=Maiale, hs_initial_published_at=1729783715853, hs_created_at=1709645745089, hs_is_edited=false, hs_deleted_at=0, name=Rob, job=, slug=rob-maiale, email=, hs_updated_by_user_id=51739740}, second={hs_id=181884577650, hs_child_table_id=0, hs_updated_at=1729782746463, hs_published_at=1739807653319, description=Niveda Ramkumar is a seasoned growth strategist with over 15 years of experience in marketing, business development, and account management at leading CROs and life science research firms. She has successfully spearheaded the launch of new services and technologies in clinical development, genomics and biomarkers, regulatory affairs, safety, and commercialization., avatar=Image{width=753,height=800,url='https://5014803.fs1.hubspotusercontent-na1.net/hubfs/5014803/niveda-ramkumar.jpg',altText='niveda-ramkumar',fileId=181890014492}, lastname=Ramkumar, hs_initial_published_at=1729782775265, hs_created_by_user_id=26433386, hs_created_at=1729782662277, hs_is_edited=false, hs_deleted_at=0, name=Niveda, job=Director, Marketing, slug=niveda-ramkumar, hs_updated_by_user_id=26433386}, third={}})
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    Rob M.

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    Niveda R.

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View some of Precision’s available biospecimens products