From The Stage

Science Can’t Be Stopped: Pushing Forward Health Breakthroughs & Hope in Uncertain Times

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

As the pharma & biotech industry is working around the clock to address the unprecedented COVID-19 health crisis, they are also giving the world hope that we will overcome these trying times. We highlight some of the important solutions in development & why we're all pushing forward: because to create new breakthroughs, you can't stop science.

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.

Key Takeaways from the 13th Annual WRIB, 2019

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

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.

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.