From The Stage

Exploratory Biomarker Testing: to Qualify or Validate the Assay?

Posted by / / BioAgilytix Insight, Biomarkers

There is a lot of confusion in the world of biomarker testing when it comes to the terms “assay qualification” and “assay validation”. These two terms are not strictly defined and are even used interchangeably at times. This confusion stems from the diverse scientific backgrounds and disciplines of those of us working in the biomarker field. Scientists from a manufacturing setting, clinical setting, or research setting have a somewhat different understanding of these two terms. Conversely, there is a clear distinction between “qualification” and “validation” for those working in analytical…

Closing Diagnostic Gaps by Anti-α-Gal IgE Immune Profiling

Posted by / / Uncategorized

I recently had the opportunity to work with a multicentric group of experts in immune profiling and immunogenic responses on the creation of a scientific peer-reviewed paper titled, “Meat allergy associated with galactosyl-α-(1,3)-galactose (α-Gal)-Closing diagnostic gaps by anti-α-Gal IgE immune profiling”. The paper, originally published in the European Journal of Allergy and Clinical Immunology in June of 2017, examines different α-Gal-containing analytes in singleplex and multiplex assays to resolve individual sensitization patterns with IgE against α-Gal. Glycoproteins and glycolipids of some mammalian species contain the disaccharide galactosyl-α-(1,3)-galactose (α-Gal), but it…

The Scientific Topics that Shaped Our 2017

Posted by / / BioAgilytix Insight, Industry Update

Throughout 2017, BioAgilytix scientists continued to establish themselves as thought leaders in the industry through the publication of blogs and industry articles, covering topics from biomarkers and immunogenicity to investing in bioanalytical technology. We thank you for engaging with our posts this year, and we look forward to sharing more about our rapidly changing industry with you in 2018. Take a look back at some of 2017’s hot topics in bioanalysis through some of our favorite content pieces: 1. Immuno-oncology: Advancing Innovative Therapeutic Options for Treating Human Cancers Learn more…

Modern Challenges of Single and Multiplex Biomarker Validation

Posted by / / Biomarkers, Industry Update

Biomarker validation can be confusing. We constantly hear about qualification versus validation, fit-for-purpose validation, and context of use. Due to the ‘grey area’ nature of biomarker work, many companies interpret these concepts and approaches differently. As scientists working on biomarker projects, we have to deal with a lot of variability between reagent and kit lots, high or low biomarker endogenous levels, and how to precisely assess antibody specificity in commercial kits, among other things. In a perfect world, we would have decisive guidance on how to manage all of these…