Althea offers cGMP plasmid production, protein production, formulation and filling services. Plasmid DNA and protein production are offered using both Althea’s industry-leading manufacturing process as well as client developed processes. A range of options are available for formulation and filling services ranging from semi- automated to fully- automated processes for vials and syringes. Althea is focused on offering highly responsive customer service, flexible scheduling, and rapid turnaround times to meet the requirements of both early stage clinical programs and commercial programs alike.

Althea Introduces Time Saving Assay for Predicting Carcinogenicity Using PCR-Based Gene Expression Profiling


SAN DIEGO – November 8, 2005 – Althea Technologies, Inc., a leading provider of innovative technologies and services for pharmaceutical development and clinical evaluation, and Natural Selection, Inc. (NSI), a leader in the application of sophisticated computational intelligence algorithms to problems in bioinformatics, announced the introduction of an novel lead compound toxicity classification assay employing multiplex gene expression screening paired with neural network analysis. The announcement of this new service for toxicological profiling will be presented at the annual meeting for American College of Toxicology, scheduled for November 6-9, in Williamsburg , Virginia . The classification of compounds into one of three categories (genotoxic carcinogen, non-genotoxic carcinogen or non-carcinogenic) is accomplished through gene expression changes measured by Althea's proprietary eXpress Profiling TM technology for multiplex PCR (XP PCR) on a select set of genes in a liver derived cell line. Evolutionary computation was used to optimize a neural network with high predictive accuracy and low probability of false positives. The key authors of the study are Gordon Vansant, Ph.D., of Althea Technologies, Inc., and Gary Fogel, Ph.D., of Natural Selection, Inc.

Lead compounds under consideration for development must undergo toxicological screening to determine if their toxicity outweighs the probable benefits. Currently, compounds planned for chronic or long-term treatment must be evaluated for non-genotoxic carcinogen activity in a two year bioassay leading to potential lost time in development of critical drug leads. This new profiling test provides a rapid method to classify lead compounds in a matter of days. As Joe Monforte, Ph.D., Vice President and Chief Scientific Officer of Althea, stated, “We're offering a fast way to assess potential liabilities of new compounds that is cost efficient and quantitative. Using quantitative multiplexed XP PCR gene expression analysis coupled with a highly predictive and accurate neural network analysis we can provide significant insight helping our clients in their plans for taking a given compound forward.” Gary Fogel, Ph.D., Vice President of Natural Selection stated, “We look forward to expanding the suite of diagnostic tests that combine the power of Althea's gene expression methods and Natural Selection's computational intelligence approaches.”

About Althea Technologies, Inc.

Althea Technologies, a leading San Diego-based pharmaceutical services firm, provides critical manufacturing and development services that support researchers worldwide in their advancement of novel therapies and efforts to apply new genomic information. Althea's GLP compliant genomic services include gene quantification using real-time PCR and gene expression profiling using XP PCR. Althea genomic services extend to the identification and characterization of new biomarkers for multiple applications including disease and compound response characterization. Additionally, Althea offers cGMP contract manufacturing of recombinant proteins, DNA-based therapeutics and vaccines, and aseptic vial and syringe filling. For more information, visit www.altheatech.com.

About Natural Selection, Inc.

Natural Selection, Inc.® was founded in 1993 to address complex problems in industry, medicine, and defense. The company possesses unique expertise in computational intelligence techniques, including evolutionary computation, neural networks, and fuzzy logic. The corporation's research efforts support the discovery of new pharmaceuticals, the automated detection and discovery of important patterns and processes in bioinformatics and medical informatics, computer-assisted diagnosis, and a variety of military and industrial projects. For more information, visit www.natural-selection.com.

Contact:

Althea Technologies, Inc.
Alan Moore
Executive Vice President & Chief Business Officer
(858) 882-0205
amoore@altheatech.com
Natural Selection, Inc.
Sarah Hahn
Director of Communications
(858) 455-6449
shahn@natural-selection.com




Althea Technologies
A leading provider of contract services to
the pharmaceutical and biotechnology industries

11040 Roselle Street | San Diego, CA 92121-1205
Toll-free 1-888-4ALTHEA
info@altheatech.com