From The Stage

Biomarker Development: Clearing the Way for Faster Biomarker Innovation

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers, Uncategorized

This spring, BioAgilytix attended The Biomarker Conference in San Diego along with other biomarker experts to discuss best practices for an industry that is still maturing in areas such as discovery, development, clinical application, and regulatory approval. A range of topics were covered, from identifying accurate biomarkers to developing standard protocols. The event ended with an exciting takeaway: while there are still many complexities involved in bringing new biomarkers to the clinic, substantial progress is already being made to create clearer paths for overcoming biomarker development challenges. Presenters at the…

The Importance of Parallelism in Biomarker Assay Development

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

Parallelism is a vitally important factor in clinical trial biomarker studies, but is still regularly overlooked in the industry. There are two definitions that I feel summarize parallelism best: Miller et. al describes it as “a condition in which dilution of test samples does not result in biased measurements of the analyte concentration”; whereas Lauren Stevenson and Shobha Purushothama define it as “a demonstration that the sample dilution response curve is parallel to the standard concentration response curve”. Essentially it means that when a test sample is serially diluted to…

‘It’s All Relative’: The Concept of Accuracy in Biomarker Analysis

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

Ligand-binding assays (LBAs) measure an analyte concentration via immunoreactivity of antibody, or binding partner, to the analyte of interest. When dealing with PK assays, reference materials are well-characterized because they are typically available in pure form and simple buffers. But in the world of biomarker LBAs, the calibrators are typically recombinant materials and therefore most often not identical to the endogenous form in the biological matrix being measured. In addition, most often it is hard to find a “clean matrix” to perform spike-recovery studies, and to confirm that the assay…

Overcoming the Challenges of Critical Reagent and Kit Lot-to-Lot Variability in Support of Clinical Trial Biomarker Studies

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / BioAgilytix Insight, Biomarkers

Critical reagents are essential components of ligand binding assays (LBA), and include many reagent categories including antibodies, engineered proteins, conjugated proteins, chemically synthesized molecules, complex biologics, and solid-supported reagents. Their unique characteristics are crucial to assay performance, and as such, they require thorough characterization and documentation. Additionally, generation and/or the purchase of critical reagents is a large investment, so setting up proper ways to manage them is extremely important to maintaining the integrity of your assays for years to come. The most important benefit of a critical reagent management system…

Taking the Stage on Bioanalytical Topics – Looking Back & Looking Ahead

Jim Datin
Posted by Jim Datin / / BioAgilytix Insight, Biomarkers, CRO Selection

Welcome to BioAgilytix’s new blog, which gives you the chance to tap the expertise and insights of our talented team on a regular basis. This forum gives us a new way to share firsthand scientific perspectives on everything from overarching bioanalytical industry trends to specific assay challenges, platform uses, case studies, and more.Like our Virtual Podium series – in which we engage industry thought leaders to share their expertise, experiences, and advice via timely, on-demand video segments – we hope that this blog will also become a valuable resource for…