By prospectively collecting tissue equivalent to those being generated by the clinical trial then it will be possible to work up completely relevant and meaningful assays prior to receiving the first patient study samples.
Histologix can undertake screening of patient biopsies using IHC & ISH methods, pre and post therapy, to identify the effects of therapy. Using the appropriate image analysis algorithms, quantified data can be compared to give an indication of efficacy.
Histologix will use IHC and ISH to characterise protein and mRNA expression from patient biopsies, using this information identify patients for inclusion or exclusion as required by the study design, eg. Triple negative patients with breast carcinoma or HPV16/18 presence.
Histologix will be able to use appropriate biomarkers to stratify patients based on IHC and ISH quantitative data that will indicate whether or not they are likely to respond to therapy.
Supporting your clinical trials Histologix offers a wide range of solutions and controls to ensure patient tissues and subsequent biomarker evaluation of each clinical trial is standardised in the most appropriate way. Standardisation is critical when comparing quantified endpoint data.
Where biomarker analysis in tissue samples is a study endpoint requirement Histologix is able to manage the areas critical to an ideal outcome;
Tissue collection, shipping and processing SOP can be provided to investigational sites. Site training
and Biopsy Kits can be employed where required.
Validated IHC & ISH assays
Digital Pathology review
Concurrent pathology reviews
Histologix provides the Pharmaceutical and Biotechnology industry with specialist pathology services to assist drug development programmes ranging from Discovery, regulatory preclinical safety testing through to clinical trials and include human tissue sourcing, histology, medical and veterinary histopathology, immunohistochemistry, digital pathology and image analysis. These are technologies that have been developed with to meet current and future requirements of targeted therapy.
Through inward investment the services provided by Histologix Ltd use a range of highly sophisticated technologies and platforms aimed at standardising the various processes involved in order to achieve data generation that is consistent, accurate and reproducible and will assist our clients in the development of their drug programmes.
Histologix is a privately owned contract research organisation that provides specialist pathology services for the Pharmaceutical and Biotechnology industry. Set up in 2005 by industry specialists, Histologix is a GLP/GCP accredited, HTA-licenced company with an extensive and impressive track record of successfully delivering a range of IHC/ISH assays to large and small Pharma/Biotechnology companies and is a preferred supplier of these services to a number of companies.
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