Pathology Nucleus is a network of senior consultant pathologists providing specialist input and oversight for pharmaceutical and biotechnology companies, CROs, central laboratories, and diagnostic and AI developers. Our engagements are fully scalable whether you need a single adjudication read, a dedicated team for the duration of a study, or complete, end-to-end management of your pathology workstream.
Specialist input and oversight for pharmaceutical and biotechnology companies, CROs and central laboratories, from a single adjudication read to end-to-end management of your pathology workstream.
We provide independent central pathology review for clinical trials, covering eligibility confirmation, histological diagnosis and subtyping.
We review case metadata and whole slide images to determine whether candidate cases meet the study eligibility criteria.
We score tissue biomarkers on immunohistochemistry and in situ hybridisation assays against a written scoring convention, including PD-L1 (TPS and CPS), HER2, Ki-67 and H-score.
We provide the independent pathologists that precision and reproducibility studies require, and monitor their consistency.
We adjudicate difficult and discordant cases, acting as an independent third reader where two pathologists disagree.
We assess tumour cell content and mark slides for macrodissection ahead of molecular and gene expression testing to ensure the tissue meets the assay requirements.
We annotate whole slide images for tumour and stroma segmentation, single-cell segmentation and immune infiltrate quantification, using consultant-approved annotation hierarchies.
We compare the output of a third-party diagnostic or AI product against consultant pathologist assessment of the same cases, report where the two agree and where they differ, and identify areas of clinical significance.
Specialist input and oversight for companies building and validating image based and language based diagnostic AI, from a single expert review to a dedicated team for a dataset build or validation study.
We review case metadata and whole slide images to determine whether candidate cases meet the inclusion criteria for a training or validation dataset.
We annotate whole slide images for tumour and stroma segmentation, single-cell segmentation and immune infiltrate quantification, using consultant-approved annotation hierarchies.
We adjudicate difficult and discordant cases, acting as an independent third reader where two pathologists disagree.
We provide the independent pathologists that precision and reproducibility studies require, and monitor their consistency.
We evaluate image based and language based diagnostic algorithms against consultant pathologist ground truth and report on accuracy, concordance, failure modes and clinical relevance.
We compare the output of a third-party diagnostic or AI product against consultant pathologist assessment of the same cases, report where the two agree and where they differ, and identify areas of clinical significance.
We review the cases a model gets wrong and identify the pathological cause of each error, such as a morphological mimic, an artefact or a rare variant.
We build benchmark cases and scoring rubrics for diagnostic algorithms and clinical large language model tools, then score the model against them and report the results.
Broad subspecialty coverage across oncological surgical pathology, haematopathology, dermatopathology, gastrointestinal and genitourinary pathology, neuropathology, paediatric pathology and laboratory medicine. Additional subspecialty expertise can be sourced according to study requirements.
Every project is led by designated consultant pathologists who are GMC-registered and/or ABPath-certified. Our team scales according to the size and duration of the study. Pathology review is conducted against pre-agreed scoring and adjudication rules, with all work documented within a robust quality management system. Work is delivered remotely and securely, in compliance with UK GDPR and HIPAA.
Pathology Nucleus provides specialist pathology services remotely, working with clients through their existing digital pathology platforms and annotation tools. Where required, we can assist with setting up suitable workflows or arrange for the review of glass slides.