The inclusion biomarkers in clinical trials results in a marked increase in the likelihood to obtain approval for the new drug. The benefit of such biomarkers in 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, be it based on biomarker discovery or prior knowledge of a gene, e.g. insights in the mode of action of a candidate drug, in the disease mechanism or in the molecular subgroups of patients.
Biogazelle combines its expertise in RT-qPCR with its quality to develop IUO tests
ready to be used in clinical trials.
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.
5 excellent reasons for choosing Biogazelle as your partner in test development
- worldwide largest and beyond industry standards track record in qPCR assay design
- test developed by the global recognized experts in gene expression analysis
- expert consultancy to support you in the development of your test
- ISO17025 accredited & GCLP-compliant labs assuring robust analytical ans clinical validation data
- highly experienced in analysis of liquid biopsies and fixed tissues