From The Stage

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.

Platform Spotlight: ImmunoCAP to Support Diagnosis of Allergic Reactions Against Biologics

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / Bioanalytical Platforms, Immunogenicity

The observation of drug-specific IgE antibodies which may cause anaphylaxis prompts the need to test for these antibodies - but because IgE are 2000-fold less prevalent than IgG antibodies, a very sensitive detection method is required. We discuss why the ImmunoCAP platform provides an ideal system to analyze IgE-mediated drug hypersensitivities.

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.

BioAgilytix Team Q&A: Meet Mike Losauro, Senior Business Development Director at BioAgilytix

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

Did you know that many of our team members have cross-functional background experience both in the lab and in customer-facing roles, making them uniquely equipped to help us deliver both high quality science and service? In this Q&A session, we talk with Mike Losauro, Senior Business Development Director at BioAgilytix, about how he applies his scientific background to his role today.

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.