HELSINKI, FINLAND, 5 November 2012: Plexpress, developer of the innovative TRAC platform for high-throughput gene expression analysis, has announced plans to extend its collaboration with the contract research organization (CRO), Admescope. The new TRACPACK INDUCTION Screening Service is optimized for screening high priority drug candidates, producing all the data required to meet FDA regulations. This involves using hepatocytes from three separate donors and generating both CYP mRNA expression and protein activity measurements. For the earlier screening of interesting compounds, the TRACPACK CYP+ mRNA Screening Service is a predictive tool that allows compounds to ‘fail early’ before significant time and resources have been utilized. To facilitate rapid and cost-effective screening this is targeted towards mRNA expression analysis only, analyzing key marker genes for drug transport, toxicity and phase II drug metabolism.
Dr. Jari Rautio, CEO of Plexpress, said: “TRAC is proving highly attractive tool for ADME-Tox related mRNA studies thanks to the numerous cost, time and accuracy benefits it offers when compared to traditional approaches such as qPCR. This interest has also likely been fueled by recent recommendations from the FDA, which suggest that measuring CYP mRNA levels provides the best way to assess drug effectiveness and tolerability (1). Combining high sample throughput with gene multiplexing to increase assay speed while minimizing technical variation, TRAC has the power to significantly boost efficiency in the laboratories of both CROs and Pharma.”
Dr. Ari Tolonen, CEO & CSO of Admescope, commented: “To more effectively meet the needs of our customer’s drug screening programs, we have diversified our ADME-Tox offering to provide both rapid early screening and in-depth analysis.” The TRACPACK-CYP+ mRNA process involves exposing HepaRG cells to a number of test compounds, at different concentrations in technical triplicate, for 24-48 hours. For added reliability, positive control inducers are also included. Following exposure, the cells are lysed in Plexpress’ proprietary TRAC lysis buffer and subjected to gene expression analysis using pre-validated TRAC panels containing up to 30 genes. These include members of the CYP family, providing a reliable indication of drug metabolism, toxicity, transport and efficacy.
TRACPACK INDUCTION expands upon the data offered by the previous service including CYP enzyme activity assays. The enhanced service also increases the number of cell donors to three, maximizing the biological relevance of the results generated and to fulfill FDA requirements. In this way, TRACPACK INDUCTION provides a single, integrated service for all CYP induction analysis, ensuring consistent and reliable data. All TRACPACK results are delivered to the customer electronically, in an easy-to-use, summarized format that makes further data analysis fast and easy.
For more information on the updated TRACPACK-CYP+ mRNA and TRACPACK INDUCTION Screening Services, please visit the Admescope website. For more information on TRAC targeted gene expression analysis visit www.plexpress.com.
1. FDA Guidance for Industry Report (Feb 2012): Drug Interaction Studies Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations
Plexpress was established as a spinoff from the Finnish Technology Research Center VTT in 2007. Including R&D at VTT, the company’s TRAC technology has been developed continuously for nearly 10 years and it has been documented in over 15 publications. The technology was originally developed for demanding bioprocess applications, which required a very robust solution for gene expression analysis. Since starting operations in 2008, the company has carried out over 50 projects using the TRAC technology in the fields of pharmaceutical development and academic research.
For further information see: www.plexpress.com
Admescope Ltd is an ADME CRO located in Oulu, Finland. The Admescope team has planned and conducted more than 800 ADME-related research projects for a high number of European biotech & pharma companies, and has published about 80 scientific papers in the field. The key expertise of the Admescope team centres around in vitro & in vivo drug metabolism, including metabolite profiling & identification using various LC/MS based techniques, drug-drug interactions and quantitative bioanalysis.
For further information see: http://www.admescope.com/