- Nov. 14, 2012 -
, 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 (http://www.admescope.com/
). 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 (http://www.plexpress.com/technology/comparisons
) 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 (http://www.admescope.com
). For more information on TRAC targeted gene expression analysis visit www.plexpress.com.Reference:
1. FDA Guidance for Industry Report (Feb 2012): Drug Interaction Studies Study Design, Data Analysis, Implications for Dosing, and Labeling Recommendations