Quantitative tissue analysis in the clinic
As a company, Visikol is a leader in advanced imaging as well as image analysis and was the first company to leverage machine learning for tissue characterization in a clinical context through its work with Enzyvant Therapeutics on RVT-802. The Visikol team is comprised of experts in imaging and image analysis as well as software development and has the ability to develop R&D software for use with clinical samples as well as 21 CFR part 11 deployable software applications for use with clinical sample characterization.
Experience with regulatory
Visikol is one of the few companies and only CRO to develop and validate digital pathology software for use in the clinic. Visikol can develop a wide range of digital pathology solutions for its Clients from simple image analysis solutions (e.g. tumor area, tumor grading and staging) to more complex machine learning based approaches. Through its work in this space, Visikol has a deep understanding of how to validate its assays and also how to develop machine learning applications that can be validated for use in a clinical context. This includes designing an analysis framework that not only answers a specific research question but also allows for quantitative validation as well as qualitative validation through follow up histopathological assessment.
To support our digital pathology assays, we can work with our Clients to generate comprehensive installation qualification (IQ), operational qualification (OQ) and performance qualification (PQ) documentation. Additionally, we can work with a Client’s internal IT and QC team to develop the required SOPs and documentation for implementation and/or to support a regulatory filing.
Approach to clinical digital pathology solutions
We begin most of our clinically-focused digital pathology projects by first executing a small scale pilot study to determine an appropriate approach and the feasibility of quantitative analysis. Some data sets are not of high enough quality for developing a quantitative image analysis based approach and we want to determine this prior to jumping into a large scale project. These initial pilot projects typically begin with a small sample size of annotated slides which can be shipped to Visikol as physical slides for scanning or digital files for analysis. Alternatively, Visikol can also process wet tissues, paraffin blocks or OCT tissues and conduct end-to-end tissue processing, labeling and scanning. Starting with a small pilot study allows for Visikol to derisk the project for its Clients and also for Clients to get a first-hand understanding of the process and types of data that can be generated so that they can more easily make the business case for their project to internal stakeholders.