SOURCE: Althea Technologies, Inc.

September 30, 2005 06:00 ET

Althea Launches GLP Clinical Gene Expression Services Using Beckman Coulter's GeXP Quantitative Multiplexed PCR System

SAN DIEGO, CA -- (MARKET WIRE) -- September 30, 2005 -- Althea Technologies, Inc., a leading provider of innovative technologies and services for pharmaceutical development and clinical evaluation, announced the introduction of Good Laboratory Practices (GLP) compliant testing services for routine gene expression analysis of clinical samples. Althea will generate quantitative gene expression data using the Beckman Coulter GeXP™ multiplexed PCR system which incorporates Althea's eXpress Profiling™ technology paired with Beckman Coulter's industry-leading capillary electrophoresis platform and automation. The GeXP™ platform is a high-throughput, highly multiplexed, PCR-based gene expression analysis technique that can be used to quantitate the gene expression values of 20-40 genes in a single PCR reaction. Initial assays include 100 gene panels for monitoring immune function, toxicological activity and oncology endpoints. Additional panels can be custom designed for each client's specific interests.

Althea is conducting this service in the specially designed GLP laboratories within the company's state-of-the-art San Diego, California facilities. This service has been integrated within the company's analytical testing group, which has been generating GLP-compliant PCR-based data since 1998 for submission to worldwide regulatory agencies in support of new product development and safety assessment. Althea's Testing Services group has successfully performed hundred's of specialized PCR studies each routinely including hundreds of PCR sample endpoints for GLP reporting. This new service line, will build upon the established GLP-compliant processes for high throughput sample extraction and processing required to deliver reliable and consistent results. Christopher Duffy, Althea's Executive Director of Analytical Services, commented, "Our ability to apply the power of eXpress Profiling™ multiplex PCR to answer important questions about targeted gene expression in ongoing clinical studies may dramatically impact the interpretation and quality of these studies. In some cases, this may give clinical researchers the tool they need to better interpret the efficacy and safety of a candidate or to structure the study to deliver the most meaningful results as economically as possible."

Dr. Joseph Monforte, Vice President and Chief Scientific Officer of Althea relayed, "The launch of this service marks the practical introduction of gene expression biomarkers as a routine, quantitative clinical testing endpoint. We will now be able to ask more specific questions in these studies going forward, with the massive array of genomic information accumulating daily."

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 services include cGMP contract manufacturing of recombinant proteins and DNA-based therapeutics and vaccines, aseptic filling, and gene quantification using real-time PCR and gene expression analysis under GLP conditions. Additionally, Althea has introduced new services and technologies for the identification and understanding of gene signatures with innovative tools such as the company's proprietary eXpress Profiling™ technology. For more information, visit www.altheatech.com.

Contact Information

  • Contact:
    Althea Technologies, Inc.
    Alan Moore
    Executive Vice President and CBO
    (858) 882-0205
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