Plexpress to hold ADME-Tox Regulatory Guidelines programmes  

Plexpress, developer of the TRAC (Transcript Analysis with the aid of Affinity Capture) platform for high-throughput gene expression analysis is running ADME-Tox programs for contract research organisations (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 This follows FDA draft guidance suggesting measurement of CYP mRNA levels for ADME-Tox studies, and EMA final guidelines stating that mRNA analysis should be used in drug interaction studies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.

The company offers an early screening package for compounds of interest and also a package for the in-depth screening of high priority drug candidates that measures both mRNA expression and enzyme activity, using hepatocytes from three different donors. CRO’s can also opt for a Partner Program scheme, an outsourced service ideal for small to medium throughput, or 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 minimise 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.”