Each year, Visikol attends the Society of Toxicology (SOT) Annual Meeting with experts in toxicology from around the world. At SOT this year, the Visikol team discussed their Visikol TOX platform for DART studies as well as their Visikol HISTO platform for the 3D visualization of spheroids.
This year Michael Johnson presented a poster on the Visikol TOX process during the conference, comparing Visikol TOX skeletal processing for DART studies to traditional KOH-based processing. The Visikol TOX technology platform has the potential to accelerate DART studies by up to 30%, allowing contract research organizations to get studies back to pharmaceutical companies more quickly. For more, check out the poster here.
Over the last few months Visikol has launched the Visikol HISTO platform for the 3D histological visualization whole tissues. The team has applied this technology in the toxicology and drug development space to specifically improve the characterization of spheroids. Spheroids are 3D cell culture models that are starting to be used frequently for the drug development process as they more accurately mimic in vivo tissues than traditional 2D in vitro models. However, until Visikol HISTO, the characterization of spheroids was limited to 2D and 1D assays that limit the utility of spheroids and the information that can be obtained.
With Visikol HISTO, we are starting to move beyond traditional single end-point spheroid assays and towards whole spheroid characterization. Instead of just receiving a single data-point from a spheroid, Visikol HISTO allows researchers to better understand how drugs are interacting in 3D with spheroid models. We started offering Visikol HISTO kits and reagents in the fall of 2016 and are currently expanding our capacity for spheroid-specific characterization assays.
Visikol TOX for DART Studies
When we first devised the Visikol TOX platform in 2014, it was not entirely clear to us the value that it would have in the toxicology field. However, through the last three years of development we have transformed this technology into a robust skeletal visualization platform for developmental and reproductive toxicology studies that increases throughput by up to 30%, reducing costs and allowing therapeutics to get to market more quickly. We recently completed the development of this platform and are now offering it for use in developmental and reproductive toxicology (DART) studies, at a cost of $650 per study.
DART studies are one of the most expensive and time-consuming components of the regulatory data required to bring a new chemical entity into the marketplace. In these studies, pregnant animals (rats, rabbits, mice) are dosed with chemicals of interest and the impact of these chemicals on the development of fetuses is investigated. While these studies entail several concurrent processes, the biggest bottleneck in this process is the gross visualization of fetuses for skeletal abnormalities.
For over 90 years, scientists have visualized the gross skeletal morphology of animals using a process called diaphonization, where bones are stained with a red dye called Alizarin (sometimes with blue Alcian cartilage staining) and soft tissues are digested away with a strong base (potassium hydroxide) to reveal the stained bones. While this process is the gold standard for skeletal visualization in all DART studies, it can take up to two weeks for fetal rabbits, can destroy tissues, and requires consistent oversight.
With Visikol TOX we have replaced this destructive and slow process with a rapid and non-destructive process that leverages the Visikol tissue clearing technology. Instead of digesting the soft tissues to visualize bone, the tissue is rendered transparent, resulting in the same endpoint in 2-4 days instead of the traditional 7 to 14 days. We recently demonstrated in a 3rd party GLP equivalency study with Product Safety Labs (Dayton, NJ) that the Visikol TOX approach was equivalent in end-point to the traditional approach while drastically reducing tissue processing time.
We have designed Visikol TOX to be a drop in replacement to traditional KOH-based skeletal processing and are currently working with several CRO’s to integrate it into their DART workflow. All of the Visikol TOX reagents to conduct a 480 fetal rat study cost $650 and the technique can accelerate overall DART study time by up to 30%.