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Tissue Cross-Reactivity Studies

TCR screening studies or GLP-compliant TCR studies suitable for IND submission

Precision for Medicine’s scientific team can perform TCR screening studies using frozen tissue microarrays or GLP–compliant TCR studies suitable for Investigational New Drug (IND) submission. Guidelines issued by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for the development of therapeutic antibodies and related products recommend their testing for tissue cross-reactivity (TCR) on a range of human tissues.

Tailored methodology for biotherapeutic tissue cross-reactivity studies

Precision for Medicine’s unique combination of research services and comprehensive tissue bank form the pillars of our TCR Services.

PFM - Parathyroid TCR

Tissue cross-reactivity study services

Combined with a tailored scientific approach, Precision’s expertise in immunohistochemistry (IHC) assay development for a range of biotherapeutic modalities enables us to deliver high-quality data to our clients in a defined time period.

  • Assay development and optimization
  • Confirmation of tissue antigenicity
  • TCR screening using frozen tissue microarrays for rapid data delivery prior to fully GLP-compliant studies
  • GLP tissue cross-reactivity studies utilizing all 36 required human tissue types
  • Fully automated IHC assays
  • Medicines and Healthcare products Regulatory Agency (MHRA) GLP-certified facility
  • In-house pathology services

Qualified biospecimens for tissue cross-reactivity studies

  • Robust qualification of tissues from procurement to assay use

  • Non-GLP tissue microarray (TMA)

  • GLP full-face sections of 36 human tissue types

Frozen-tissue-microarray

Guide to successfully conducting tissue cross-reactivity studies

Whitepaper

Guide to Successfully Conducting Tissue Cross-Reactivity Studies

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Guide to Successfully Conducting Tissue Cross-Reactivity Studies

Tissue types available for GLP TCR studies

Precision for Medicine is a leading supplier of well-characterized biospecimens for research—all collected through a global network of healthcare specialists. All human tissues recommended for TCR testing by the FDA and the EMA are fully consented for commercial research, and available from at least 3 male and 3 female donors.

Tissue types are available from multiple male and female donors
Adrenal gland lleum Prostate
Bladder Kidney—glomerulus and tubule Skeletal muscle
Blood cells Liver Skin
Blood vessel endothelium Lung—bronchus and parenchyma Spinal cord
Bone marrow Lymph node Spleen
Breast Ovary Stomach
Cerebellum Pancreas Testis
Cerebral cortex Parathyroid gland Thymus
Colon Parotid salivary gland Thyroid gland
Eye Peripheral nerve Tonsil
Fallopian tube Pituitary gland Ureter
Heart Placenta Uterus—cervix and endometrium

Precision’s 3-phase approach to TCR testing

Tissue-cross-reactivity_Diagram-1

Learn more about Precision’s tissue cross-reactivity capabilities

Brochure

Brochure: GLP Tissue Cross Reactivity Testing

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Brochure: GLP Tissue Cross Reactivity Testing

Integrating biomarker and clinical trial data

To help researchers understand and interpret biomarker assay data in the context of other assays as well as the clinical trial data, Precision manages all assay data using our proprietary QuartzBio® Translational Informatics platform.

Learn more about the sample management, informatics, and computational capabilities of QuartzBio®.

Global reach, multi-site support

We provide TCR study services that support preclinical research conducted anywhere in the world, with specialty labs located in North America and Europe.

Working with Precision

Precision’s specialty lab scientists take collaborative and consultative approaches to projects and can provide recommendations on biomarker assay strategies and implementation. Services can be provided individually or as part of a comprehensive therapeutic development package including biomarker assays and clinical trials.

Discover the Precision blog

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

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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=1736962071401, 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=26433386}, second={hs_id=159488778840, hs_child_table_id=0, hs_updated_at=1716132440837, hs_published_at=1736962071401, 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=26433386}, third={}})
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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=1736962071401, 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=26433386}, second={hs_id=181884577650, hs_child_table_id=0, hs_updated_at=1729782746463, hs_published_at=1736962071401, 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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