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The inclusion of biomarkers in clinical trials results in a marked increase in the likelihood to obtain approval for the new drug. The benefit of such biomarkers is nicely reflected in the steady increase of biomarker usage in clinical trials with 28% of novel new drugs approved by FDA being precision (personalized) medicines in 2015 (source: Amplion)
Biogazelle can assist in the different phases of biomarker development, such as through biomarker discovery or, if the gene is known, by providing insights in the mode of action of a candidate drug, elucidating the disease mechanism or by helping to classify patient cohorts into molecular subgroups.
While RNA sequencing is used as preferred technology for biomarker discovery, RT-qPCR constitutes the platform of choice for clinical and diagnostic applications. Therefore, Biogazelle combines its expertise in both platforms to perform a technology switch from RNA sequencing to RT-qPCR. This involves the development of qPCR primers for all genes within the candidate multi-gene signature, that are subsequently validated on the samples from the discovery cohort. Biomarker proof-of-concept studies are completed by performing a more thorough analytical validation of the RT-qPCR assay followed by a scientific validation of the potential of the biomarker in an independent cohort.
Following a positive biomarker proof-of-concept study, a biomarker test is converted in an investigation-use-only (IUO) test that can be used in clinical trials. Biogazelle combines its expertise in RT-qPCR and its quality standards with external support regarding the regulatory aspects to develop IUO tests ready to be used in clinical trials. Finally, Biogazelle can perform the biomarker analysis for clinical trials in-house, and, if necessary, transfer the biomarker to other specialty labs.