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 but yet maintains interest in novel targets that while have the potential to have great impact, by target an small population or have unproven broader utility. We believe that 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
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A pilot study to assess inflammatory biomarker changes when raltegravir is added to a virologically suppressive HAART regimen in HIV-1-infected patients with limited immunological responses.
Lichtenstein KA, Armon C, Nagabhushanam V, Efaw BJ, Frazer-Abel A, Hiserote ME, Alam R.
Antivir Ther. 2012;17(7):1301-9. doi: 10.3851/IMP2350. Epub 2012 Sep 5.