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CLC Bio, Roche to Develop FFPE Analysis Platform to Support MDx, Revive Drugs

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CLC Bio and three other collaborators are developing a new biomarker analysis platform with an eye toward improving drug developers' ability to resuscitate treatments that have previously failed to advance in clinical trials.

This week, CLC Bio announced that it is working with Aros Applied Biotechnology, F. Hoffmann-La Roche, and the Institute of Pathology and the Research Unit for Molecular Medicine at Aarhus University Hospital to develop a solution for large-scale use of formalin-fixed, paraffin-embedded tissue in molecular analyses.

The main application areas for the platform "will be molecular diagnostics research and re-analysis of pre-clinical trials where drugs have failed despite relatively high rates of positive responses," the company said in a statement. The platform is expected to help researchers select appropriate FFPE samples, choose the optimal sequencing technology for analyzing those samples, and subsequently assemble and analyze the resulting sequencing data.

CLC Bio and the Danish National Advanced Technology Foundation will each spend $2.5 million to develop the platform.

According to Stephen Dutoit of Aarhus University Hospital's Institute of Pathology, "having access to high-throughput genomic analyses of the vast number of existing archive FFPE samples" will help advance therapies that are individualized at a genomic level.

Roald Forsber, director of scientific development at CLC Bio, added that tissue samples and corresponding clinical data on patients represent a "unique biobank," but "until now there hasn't been a high-throughput solution for collecting, sequencing, and analyzing DNA extracted from FFPE tissue samples."

CLC Bio will have access to Aarhus University Hospital's samples in developing and validating the platform, which the company believes could attenuate the lack of access to fresh tissue samples that sometimes slows down genomic analysis at academic centers and at pharmaceutical companies.

"Using the proposed platform, researchers will have access to vastly more samples than can be collected in traditional fresh tissue biobanks," CLC Bio explained. "Equally important, these samples can be efficiently linked to high-quality patient data through numerous healthcare, disease, and population registries, providing unique opportunities to boost research in disease mechanisms and rescue drugs from failure."

Roche's involvement in the project suggests that the platform, when ready for prime time, may be used to develop tests, individualize drugs, and may be even resuscitate previously failed treatments in genetically defined subpopulations of patients. Roche is one of the few companies in the industry with the capability to develop both personalized drugs and their companion tests.

CLC Bio did not respond to questions prior to press time.

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