From The Stage

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.

Podcast Feature: Enabling the Breakthroughs of Tomorrow, Today

Jim Datin
Posted by Jim Datin / / CRO Selection, Industry Update

BioAgilytix’s President and CEO, Jim Datin, sat down to discuss the exciting growth trends in large molecule development, and how BioAgilytix is growing in kind to support the increased need for specialized bioanalysis to accelerate these innovative therapies to market.

Immunogenicity Assessment of Gene Therapy Compounds

Dr. Arno Kromminga
Posted by Dr. Arno Kromminga / / Gene Therapy, Industry Update

By Dr. Arno Kromminga and Dr. Lydia Michaut
Gene therapy has experienced an exciting resurgence in the post-genomic era, but unwanted immunogenicity is still a concern. Our latest blog gives insight into the current concepts for designing an immunogenicity assessment strategy fitting the specific needs of a given gene therapy compound.