HistologiX is a GLP and GCP accredited CRO who provide a full range of high quality histopathology and IHC services to support pre-clinical and clinical R&D, immuno-oncology and biomarker research. We have extensive experience in custom IHC assay development, offering assay optimisation and validation, and can provide digital image analysis using a wide range of algorithms.
Our core capabilities include:
Histopathology and Specialised staining
Chromogenic and Fluorescent IHC assays
Immuno-oncology and specialist multiplex assays
Pre-clinical assay validation to take through to GCP clinical trials
Digital Pathology and Image Analysis (Halo™) with interpretation
Medical and Veterinary Pathologists
Antibody Cross-Reactivity studies to GLP
We run assays on the Ventana, Leica Bond and LabVision automated staining platforms, and digitally scan stained slides using our Hamamatsu brightfield slide scanner or fluorescence using the Zeiss Axioscan.
Analysis can be via digital image analysis and/or Pathologist interpretation. With regards to clinical trials, HistologiX can assist in patient recruitment stratification, advice to clinical trial sites regarding tissue collection and handling, and of course blinding.
In addition, we can provide high quality tissue and bio-fluid samples. Working with reputable sources worldwide and specialising in ethically sourcing biological material linked to extremely detailed genotypic, phenotypic, environmental and biomedical data, where appropriate. We now have over 200 active sources of human biosamples and access to banked human tissues and can set up prospective collections in the UK, Mainland Europe and USA.
HistologiX provides expert services in support of regulatory pre-clinical toxicology studies, clinical trials studies, non-regulatory histology, veterinary and medical research studies in tissue from humans and animal species. 100% quality control of all slides
We can provide services from any point in the histopathology process, from wet tissue trimming through fixation, processing, embedding, sectioning to image analysis and reporting. Standardised and custom trimming planes, blocking codes and species specific processing schedules, decalcification, megablocks, step serial sections, standard H&E or client specific H&E staining used. Reading and reporting by highly experienced Industry Veterinary Pathologists.
Services include the demonstration of protein expression for therapeutic antibody cross-reactivity (TCR), cell signalling, proof of principle, proof of mechanism biomarkers, pre- and post- therapy clinical trial biopsy screening, IHC assay development of novel antibodies, aptamer staining. We use frozen or FFPE tissue samples and can provide IHC assay development or transfer-in client’s methods which we will validate. Histologix uses Ventana Discovery XT and Ultra, Leica Bond Rx in addition to LabVision systems. Histologix can provide multiplex staining assays in order to demonstrate two or more targets in the same section by chromogenic or fluorescent methods.
IHC assay development is a strength of HistologiX. We are experienced in working up assays for commerical antibodies, novel and theraputic antibodies. This can be via brightfield or fluorescent assays, and multiplexing is a key capability.
Our scientists have an exccellent reputation in assay development, and troubleshooting, to give our clients the best results while maintaining good communications with our Clients throughout the process.
HistologiX undertakes regulatory and non-regulatory testing of novel therapeutic monoclonal antibodies in normal an animal tissues as outlined by the USA FDA, EU and Japanese MAFF regulators.
Fully consented human and animal tissues obtained, optimised working assay conditions for each antibody, screening 38 frozen human tissues from a minimum of 3 donors. Non regulatory screening can be performed by using TMA’s to identify suitable Mab clones.
Molecular classes screened: murine, humanised, chimeric, fully human, antibody cocktails, Fab/VH fragments, bispecific superantigens, biomers, tetramers, Darpins, nanobodies, multispecific nanobodies, aptamers and variable regions attached to various carrier backbones)
Histologix is able to provide digital scanning services through the use of the Hamamatsu NanoZoomer and Zeiss Axioscan (for fluorescence). Scanning at magnifications of x20 and x40, Histologix will generate high quality images of your BF and FL slides. These images are used for analysis.
Our secure cloud server allows you to remotely access these images in an instant from your office. For archiving purposes we can load these images onto external hard-drives for you.
HALO is the gold standard image analysis platform for quantitative tissue analysis in digital pathology. HistologiX employs image analysis specialists who are proficient in tissue recognition, algorithm optimisation and data reporting with interpretations.
The tools that we use to help automate tissue segmentation, such as tissue classifier, serial section analysis, and TMA. HALO reports morphological and multiplexed expression data on a cell-by-cell basis across entire tissue sections and maintains an interactive link between cell data and cell image. For example, cells can be sorted according to biomarker intensity and immediately locate cells with highest intensity in the image. Our image analysis scientists can aid your drug devlopement through quantitative analytics of your IHC biomarkers.
HistologiX has a number of consultant expert Veterinary Pathologists that are Board Certified, and highly experienced in the field of regulatory toxicology. Histologix has worked closely with these Pathologists over a number of years and we are confident of their ability to deliver highly accurate evaluations and timely robust reports.
Medical Pathologists support our clinical studies. These medical Pathologists most of whom have areas of sub-specialityprovide in-depth scientific input into your study design, expert histopathology reports and peer review reports.
Histologix is able to provide you with the highest quality FFPE archive tissue, snap frozen unfixed samples and material from prospective collections of a range of normal and diseased tissue. T
With GCP accreditation, HistologiX has completed analysis of many Phase I/II Clinical Trial sample reporting. This is generally for pre-and post-therapy biopsy analysis, with Pathologist scoring endpoints, or exploratory image analysis endpoints.
We have SOPs and can advise on tissue handling protocols, standard ischemia, fixation & processing, patient recruitment and stratification, patient confidentiality and blinded trials.
Study specific or Process specific QA audits are carried out when required.
Our internal QA department conducts study-specific and process-specific audits in line with the UK Governing bodies to maintain our GLP and GCP acceditation.
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HistologiX Ltd has not received any endorsements.