Clinical Trials

Clinical Trial Support

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.

Patient recruitment

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.

Patient stratification

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.

Study Design for Tissues

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 Handling Protocols

Tissue collection, shipping and processing SOP can be provided to investigational sites. Site training
and Biopsy Kits can be employed where required.

Sample testing

Validated IHC & ISH assays
Image analysis
Digital Pathology review
Concurrent pathology reviews

Digital Pathology

Using digital scanning services, Histologix will provide images via a secure cloud server to our pathologists to enable remote evaluations.

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