From The Stage

Webinar Sneak Peek: Exploratory Biomarker Testing—to Qualify or Validate the Assay?

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

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.

C-Path “Points to Consider Document” Clarifies Bioanalytical Assay Validation in Support of Clinical Biomarker Qualification

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / Biomarkers, Industry Update

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.

510K Approved Assays vs. RUO Assays: Which Best Support Clinical Trial Biomarker Studies?

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

Platform Spotlight: ProteinSimple Ella™ for Accurate and Reproducible Multiplex Biomarker Analysis

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

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.

A Dose of Pharma and Biotech News: February 13, 2019

Jim Datin
Posted by Jim Datin / / Biomarkers, Industry Update

We find it critical to stay on top of the latest industry developments to inform our own work and help our customers best address emerging bioanalytical challenges and opportunities; we've compiled some of our favorite recent industry articles of interest to share with you.

Exploratory Biomarker Testing: to Qualify or Validate the Assay?

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / 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…

Modern Challenges of Single and Multiplex Biomarker Validation

Dr. Afshin Safavi
Posted by Dr. Afshin Safavi / / 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…