HistologiX

Histologix is a GLP/GCP/UK HTA accredited CRO providing services related to histology and immunohistochemistry IHC. Initially set up in 2005 when we gained GLP accreditation following inspection by the UK GLP monitoring authority – MHRA – and retained in 2007, 2010 AND 2012. Our area of focus combines human tissue access, oncology tumour cell lines and xenografts in Nude and SCID mice, Pharmacology PK/PD, histology, immunohistochemistry, in situ hybridisation (RNAscope), automated Ventana platforms, molecular assays, multiplexing technology, Pathologists, digital scanning technology and image analysis to deliver biomarker strategies aimed at providing subjective and quantitative endpoint data to support your drug development programmes from early discovery phases through to clinical trials. And we have worked either end of this spectrum. From target validation to therapeutic efficacy, preclinical screening and patient biopsy screening in clinical trials, Histologix has experience in a wide range of screening techniques to realistically offer solutions throughout the development process.

Services – Target validation, mutational studies using ISH RNAscope, quantitative efficacy studies in xenografts, cytokine release assays, target distribution studies, Biosimilar strategy for antibody therapeutics and biologics, downstream cell signalling protein surrogate quantification, companion diagnostic prototype development, regulatory cross-reactivity studies for therapeutic antibodies (including antibody fragments, nanobodies, multispecific molecules, etc), POP and POM studies.

Therapeutic Areas - Angiogenesis/atherosclerotic plaque analysis/fibrosis analysis, Diabetes alpha/beta cell mass, insulin/glucagon IHC staining, Oncology/tumour growth/cell proliferation/cell death, Inflammation/RA/Psoriasis. We would like to be able to provide you with services at different stages throughout the drug development process and with different clients we have worked each of these stages.

1. Proof of principal/mechanism studies lend themselves nicely to using tissue expression techniques that will demonstrate target staining on target cells.

2. Antibody/target validation

3. Mutational studies targeting DNA rather than protein expression can be useful especially where proteins do not work or to demonstrate tumour mutations, eg. KRAS, EGFR, bax, Bcl, etc

4. Efficacy studies using over-expressing cell lines/xenografts where cell lines are engineered to express at different levels and would also include knock-down cell lines/xenografts. Quantitative endpoints are critical to collecting comparable data and in turn standardisation of tissue handling protocols, fixation and processing of tissue and IHC/ISH staining protocols are essential to minimising artefact thereby increasing the confidence in the data generated.

5. Target distribution studies in normal and diseased tissues. Where feasible use of TMA’s would be combined with image analysis to generate with large amounts of digital data.

6. Tumour and Stromal inflammatory cell phenotyping

7. Downstream surrogate cell signalling protein expression which can be potentially used to generate companion diagnostics.

8. The development of a companion diagnostic prototype which can be predictive of patient response to therapy and subsequently used to stratify patients for inclusion into a clinical trial or treatment regime. Using different levels of over-expressing cell lines in xenografts IHC staining of the downstream surrogate target protein can be repeated and compared to highlight staining at each level of expression. The process can be repeated by different people on different days in different laboratories to obtain consistency, reproducibility and robustness of the assay.
Development of a diagnostic kit thereafter would need to go companies such as Dako.

9. IHC/ISH expression in tissues or cell lines or xenografts can be used to set up strategies for Biosimiliar product development.

10. Therapeutic antibodies will need to be screened in normal tissues to demonstrate which targets they bind to other than their intended targets. Molecules may include human or humanised antibodies, fragments, variable regions, or variable regions attached to carrier molecules, aptimers, nanobodies, multispecific nanobodies, etc.

11. Full digital pathology services including whole slide scanning and uploading to secure cloud server for remote access, Indica Labs HALO image analysis with quantification of nuclear, cytoplasm, membrane cell compartments, microvessel density, fluorescent and chromogenic single/multi-spot counts for FISH, SISH, and DISH, same section co-localisation for chromogenic dual IHC staining and fluorescent triple staining, and many more alogorithms.

12. Teams of senior MEDICAL PATHOLOGISTS many with areas of sub-speciality together with VETERINARY PATHOLOGISTS are available to evaluate preclinical and clinical trial studies.

13. To phenotype and Quantify stromal and tumour imflammatory cells pre and post therapy which will give some indication of patient survival.