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Capitalizing on FDA Guidance, Plexpress, Admescope Expand TRAC Services

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Plexpress and Admescope announced plans this week to expand the scope of Plexpress' TRAC expression profiling services that Admescope, a contract research organization, offers to its pharmaceutical clients.

The expanded services are intended to capture business from pharma customers who are interested in following draft guidance issued by the US Food and Drug Administration in February that suggests that CYP mRNA analysis could be more informative than measuring CYP protein activity for drug metabolism studies, according to Plexpress CEO Jari Rautio.

Specifically, Oulu, Finland-based Admescope will now offer Plexpress' TRACPack Induction assay for screening high-priority drug candidates. According to the companies, TRACPack Induction uses hepatocytes from three separate donors to generate both CYP gene family mRNA expression and protein activity measurements.

Both of the services are performed in either a 48- or 96-well format, and turnaround time for the service is about three weeks, the firms said.

For the earlier screening of interesting compounds, Admescope will offer TRACPack-CYP+ mRNA screening, a predictive tool that analyzes many compounds at once, enabling compounds to "fail early before significant time and resources have been utilized," according to the firms.

"Drug development companies are specifically asking CROs for mRNA measurements due to the change in [FDA] recommendations," Rautio told BioArray News this week. "Therefore many preclinical CROs who did not previously offer mRNA measurements in their service portfolio are now looking for solutions, which has increased interest in Plexpress services."

He added that Plexpress launched its prevalidated CYP panels before the FDA recommendations, "so the timing has been opportune."

Helsinki, Finland-based Plexpress is a privately held company that was established in 2007 to commercialize TRAC, which stands for Transcript Analysis with the aid of Affinity Capture. According to the firm, TRAC relies on a set of amplifiable detection probes and biotinylated oligo-capture probes that are hybridized in solution. The resulting sandwich hybrids are collected on magnetic streptavidin-coated microparticles and washed. The hybridized probes are then eluted and detected with laser-induced fluorescence and capillary electrophoresis. TRAC has been adapted to work in a 96-well format, allowing users to profile the expression of 30 genes in each well.

Plexpress earlier this year announced a deal with Admescope to allow the CRO to offer the TRAC platform to its clients to investigate in vitro drug interactions and preclinical ADME-tox responses (BAN 5/22/2012).

Admescope CEO Ari Tolonen said in a statement that the CRO decided to expand its services to "effectively meet the needs of our customers' drug-screening programs," and that the addition of TRACPack-CYP+ mRNA and TRACPack Induction will diversify Admescope's offering to "provide both rapid early screening and in-depth analysis."

According to the firms, TRACPack-CYP+ mRNA involves exposing HepaRG cells to a number of test compounds, at different concentrations in technical triplicate, for between 24 and 48 hours. Following exposure, the cells are lysed in Plexpress’ TRAC lysis buffer and subjected to gene expression analysis using prevalidated TRAC panels containing up to 30 genes, including members of the CYP family.

TRACPack Induction, meantime, includes CYP enzyme activity assays. The induction service also increases the number of cell donors to three, "maximizing the biological relevance of the results generated" and fulfilling FDA requirements, according to Plexpress.

According to Rautio, the main competitive technology is real-time PCR rather than traditional expression arrays. He noted that Admescope used Life Technologies TaqMan assays for mRNA induction studies of key CYPs assays in early phase screening prior to switching to the TRAC platform.

"CYP+ screening for between 20 and 30 target genes in hundreds of samples is not convenient for TaqMan or other PCR platforms, meaning that other gene expression methods are not feasible alternatives," said Rautio. "CYP+ mRNA screening provides direct mRNA induction data that serves as important preliminary data for subsequent FDA-required studies. In addition, CYP+ offers predictive data of transport, tox, and phase II markers."

Plexpress makes TRAC available via a number of CROs and partners, including SBW, another Finnish company, as well as Taiwan-based Phalanx. Admescope is so far the only one of Plexpress' partners to offer the new services. But Rautio said that Plexpress has a non-exclusive arrangement with Admescope, meaning that other partners could soon offer the services too.