FDA PURCHASES LEADSCOPE ENTERPRISE AND THE TOXSCOPE TOXICITY DATABASES.

LeadScope Inc. has announced that the U.S. Food and Drug Administration (FDA) has purchased the LeadScope Enterprise software and the ToxScope toxicity databases to assist in its "in silico" toxicology assessment.

Earlier this year, LeadScope announced that it is collaborating with the FDA under a Material Transfer Agreement (MTA) that provides the FDA with limited access to the LeadScope technology. This agreement is with the Center for Drug Evaluation and Research (CDER) and the Center for Food Safety and Applied Nutrition (CFSAN). The FDA is now extending its use with this purchase.

"We are extremely excited and flattered that the FDA has chosen to purchase LeadScope Enterprise and ToxScope for data mining and toxicity prediction of new chemical entities," commented Pamela Springer, Vice President of Sales for LeadScope Inc. "The FDA will be able to use both the public toxicity information, provided in the ToxScope toxicity databases, along with their own proprietary information to identify relationships between chemical structures and toxicity."

"The FDA expects to use LeadScope in its safety assessment of food contact materials," said Dr. Mitchell A. Cheeseman of the FDA. "We expect the software to be particularly useful in resolving safety questions concerning the potential mutagenicity of food contact substances."

LeadScope's mission is to accelerate the drug discovery process by integrating data from throughout research and development, and visualizing the information it contains. The company provides solutions by bundling new value- added content (databases) along with advanced visualization, analysis, data mining and techniques for content-based prediction.

LeadScope Enterprise is a chemically intelligent informatics platform that rapidly identifies correlations between chemical structural features and any biological endpoint, such as toxicity. The chemical sub-structural hierarchy within LeadScope's platform contains a comprehensive set of molecular features (27,000) organized for easy navigation. The ability to integrate the chemical and biological screening data in combination with the chemical hierarchy allows scientists to understand the relationship between molecular sub- structures and biological screening data.

The ToxScope toxicity databases encompass acute toxicity, hepatotoxicity, mutagenicity and carcinogenicity. ToxScope enables the user to make side-by- side comparisons of efficacy screening and toxicity information, use structural alerts from any source, explore chemical space of any data set and manage complex in-house data.