From the FDA perspective “a biomarker is a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or biological responses to a therapeutic intervention”. As such biomarkers present a clearly very powerful potential but the challenge can be moving a promising biomarker from your laboratory to an environment where it could be utilized for a clinical trial, patient stratification or even as part of a patient diagnostic picture. To do this you may need a partner, but one who spans the different regulatory requirements while maintaining interest in novel targets that while have the potential to have great impact, by targeting a small population or have unproven broader utility. We believe that our Exsera Biomarker laboratory could be the partner for you. At Exsera BioLabs, we believe in the power of innovations and that starting small does not mean that you can’t have a big impact on people’s lives. Therefore, we look forward to talking to you about translating your biomarker into an offerable test.
Custom assay transfer and validation
Custom assay development and validation
For further information and to discuss the possibilities:
exserabiolabs@ucdenver.edu
Queries can also be submitted using the form below.
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