Guidelines issued by the U.S. 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.

Precision for Medicine’s scientific team can perform TCR screening studies using frozen tissue microarrays, or fully good laboratory practice (GLP)-compliant TCR studies suitable for Investigational New Drug (IND) submission.

 Tailored methodology for biotherapeutic tissue cross-reactivity studies

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

Tissue crossreactivity 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

(Frozen TMA for TCR screening)

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

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.

Precision’s 3-Phase Approach to TCR Testing

Learn more about Precision’s tissue cross-reactivity capabilities

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 pre-clinical 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.

Related Services

Immunohistochemistry (IHC)

Precision’s immunohistochemistry (IHC) services can be customized based on study needs, and can include development of logistical processes, kitting, special stains, and creation of a custom assay and scoring system.

Pathology Services

Our in-house pathology team can provide expert assessments with rapid turn-around times, and has a full suite of sample processing services including formalin-fixed, paraffin-embedded (FFPE) and microdissection for genomics applications.

Multiplex Immunofluorescence

We offer automated multiplex immunofluorescence (mIF) services that enable quantitative visualization of as many as 9 markers in tissue and liquid biopsies, and individual cells. mIF can be integrated with other methods including co-analysis using fluorescent in situ hybridization/in situ hybridization (FISH/ISH).

Discuss your project requirements

Whether you know exactly the type of immune monitoring approach you need or would like expert support with project design, we can deliver.

Discuss your project requirements

Whether you know exactly the type of immune monitoring approach you need or would like expert support with project design, we can deliver.

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