Translational Research - Biomarkers - Assays
Immunohistochemistry in Precision Medicine: From Biomarker to Clinical Trial Assay
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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.
Precision for Medicine’s unique combination of research services and comprehensive tissue bank form the pillars of our TCR 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.
Robust qualification of tissues from procurement to assay use
Non-GLP tissue microarray (TMA)
GLP full-face sections of 36 human tissue types
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 |
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®.
We provide TCR study services that support preclinical research conducted anywhere in the world, with specialty labs located in North America and Europe.
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.
Read our blog to gain more insights and discover work that Precision has supported.
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Whether you know exactly the type of immune monitoring approach you need or would like expert support with project design, we can deliver.