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Many great questions were asked by our audience during Dr. Afshin Safavi’s recent webinar on exploratory biomarker testing. We've compiled his answers those he didn’t have time to address during the live session.
Biomarkers are endogenous molecules with much individual variability, and there is still not yet one clear and concise guidance for biomarker validation – so there are still questions around what it takes to sufficiently validate the performance characteristics of a biomarker assay to ensure it can properly establish the value of the target biomarker as a qualified DDT.
A contributing author to the Critical Path Institute (C-Path)’s “Points to Consider Document,” Dr. Afshin Safavi summarizes considerations outlined in the paper designed to establish consensus on the expectations for the validation of assays used in the regulatory qualification of fluid biomarkers.
The answer to the question is “it depends”. Commonly a combination of 510K approved kits (in Europe known as assays that need to follow IVD-directive 2017/746) and research use only (RUO) kits are used to support the biomarker analysis needed in clinical trials because both types of assays have different strengths and limitations. To select the appropriate kit requires an understanding of these pros and cons in the context of the intended study the assay must support.
There is no doubt that our genetic makeup is different. Yet surprisingly, biology is often an overlooked consideration in ensuring biomarker assays are set up and validated to support the intended study.
Last month at WRIB, our scientific team had the opportunity to participate in a number of discussions surrounding the latest topics of interest in biomarkers, immunogenicity, and regulatory standards. We wanted to share some of the event takeaways we found most interesting and valuable.
Couldn’t make the Oxford Global’s 14th Annual Biomarkers Congress? Read our recap of the key opportunities and challenges in biomarker development that scientists discussed.
When assessing biomarkers for multifactorial diseases, we ideally want to assess multiple analytes in the same experiment. That is where the value of multiplex biomarker analysis comes in – but this method also inherently creates potential challenges with cross-reactivity. We discuss how the ProteinSimple Ella platform enables multiplexing with excellent assay reproducibility, and how it can benefit studies with low sample volumes.
Consistent discussion and improvement upon the standard practices of bioanalytical laboratories is critical to improving the work we do supporting innovative biologics development in the long-term. One of the rapidly advancing areas that is being regularly discussed in the industry is the evolution of ligand-binding assay (LBA) platforms. In this blog, I will summarize best practices and characteristics associated with LBA platforms as well as the features these platforms absolutely need to enable scientists to respond to industry pressures that drive demand for increasingly complex bioanalysis, condensed timelines, and continued…
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