SBIR Phase I: Improved Skeletal Visualization Technology for Developmental and Reproductive Toxicology (DART) Studies

The broader impact/commercial potential of this Small Business Innovation Research (SBIR) project will be to develop technology to improve skeletal visualization for developmental and reproductive toxicology (DART) studies. Every year over $4 billion is spent in the US on toxicology studies for new pharmaceuticals, cosmetics, pesticides, and industrial chemicals. Any reduction in testing times or costs could create significant benefits to these industries by bringing safer chemical products to market more quickly and at lower costs. Using this technology would reduce both researcher time and the number of laboratory animals needed to complete common studies, leading to faster and more efficient safety screening for new chemicals. The aim is to enable contract research organizations (CRO's) to conduct 30% more studies per year while reducing costs. These studies are required to ensure that chemicals that make it into the market place are safe. CRO's that conduct these studies currently have a very challenging time meeting customer demand. The demand for DART studies has risen quickly due to the recent REACH legislation in the European Union, and the back-log has resulted in chemicals and life-saving therapeutics being available to consumers more slowly. This SBIR Phase I project proposes to develop a clearing agent for the visualization of bone structures in rodents. The goal is to demonstrate the proposed technology can rapidly clear tissue without causing damage to the specimens. The major problem with the currently used method, diaphonization, is its tendency to destroy specimens beyond usability, and the time required to complete the process. Currently, the longest step is processing the animals to evaluate their skeletons, which is conducted using a process requiring 14-21 days where the soft tissue is digested with a strong base and the bones are stained so they can be more easily visualized. The proposed technology is able to render the soft tissue transparent so that the bones can be easily visualized in 2-6 days. Through this project the technology will be optimized for replacing the current approach to skeletal visualization in DART studies, and then compared in a side-by-side study to determine if the same end point is reached without damage to the specimens while reducing overall study time by over 30% and reducing costs. This project will lead directly to a technology that can be sold to CRO's to replace their current skeletal visualization technology with an approach that enables them to drastically increase study throughput and quality.