EMA and FDA recommend mRNA testing in ADME-Tox studies for superior sensitivity

Plexpress, developer of the innovative TRAC (Transcript Analysis with the aid of Affinity Capture) platform for high-throughput gene expression analysis,has announced dedicated ADME-Tox programs for contract research organizations (CROs). This follows FDA draft guidance suggesting measurement of CYP mRNA levels for ADME-Tox studies, and EMA final guidelines stating that mRNA analysis should be used in drug interaction studies in order to increase the sensitivity of assays.

Plexpress has developed two ADME-Tox screening services for CROs to ensure compliance with regulatory guidelines. For the early screening of compounds of interest, the TRACPACK CYP+ mRNA Screening Service quickly and efficiently identifies unsuitable compounds, allowing them to ‘fail early’ before further time and money is invested. This service specifically analyzes mRNA expression of the key ADME-Tox markers in a time and cost-effective manner. Plexpress’ TRACPACK INDUCTION, has been developed for the in-depth screening of high priority drug candidates generating data that completely fulfills the global guidelines. TRACPACK INDUCTION measures both mRNA expression and enzyme activity, using hepatocytes from three different donors.

TRAC’s unique multiplexing with high sample throughput fills the gap between microarrays and traditional targeted approaches such as qPCR, offering numerous time, cost and accuracy benefits to alternative methods. Plexpress is offering two easy ways for CRO’s to incorporate TRAC into their workflow. The Plexpress Partner Program, an outsourced service which is ideal for small to medium throughput, and the Plexpress Licensing Program suited to a higher throughput with TRAC assays undertaken in-house by the CRO.

Dr. Jari Rautio, CEO of Plexpress, said: “In light of recent recommendations, drug companies are requesting mRNA data for CYP targets to fulfill regulatory guidelines. Our TRAC CRO services and products have been designed to fulfill this exact need and are highly attractive tools thanks to the numerous benefits they offer in comparison to other technologies. TRAC combines gene multiplexing with high sample throughput to increase assay speed and minimize technical variation, providing significant economic and efficiency boosts. We have made it easy for CROs to incorporate TRAC into their workflow with our dedicated Plexpress Partner Program and Plexpress Licensing Program allowing them the choice of outsourcing or fully supported in-house set-up.”

To find out more about the options and benefits of TRAC in your workflow please visit the company’s CRO page.

For general information please visit the Plexpress website at www.plexpress.com