To the Rescue: Applying a Novel Approach to Minimize False Positive ADA Assay Results
Target interference can cause false positive ADA assay results and stall out promising drugs. This could have been the case for one study involving an…
BioAgilytix Team Q&A: Meet Mike Losauro, Senior Business Development Director at BioAgilytix
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…
Your Questions About Immunogenicity Assessment of Gene Therapy Compounds Answered
The webinar I recently hosted with my colleague Lydia Michaut explored key challenges and trends in the immunogenicity assessment of gene therapy compounds. This recap…
A History of Gene Therapy: Exploring Lessons Learned In Light of New Approvals
The FDA recently approved the first gene therapy for pediatric patients with SMA, signifying a major step forward for the therapeutic field as a whole.…
Key Takeaways from the 13th Annual WRIB, 2019
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 Assessment of Gene Therapy Compounds
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…
The Fit for Flow Cytometry, Part 1: Ideal for Receptor Occupancy Assessment
Flow cytometry is an ideal platform for many applications involving the study of complex cell populations. In the first blog of our new “The Fit…
New FDA Guidance on Developing and Validating Assays for ADA Detection: Key Updates and Clarifications
The FDA’s recently released new guidance, designed to facilitate development and validation of assays for the detection of anti-drug antibodies for immunogenicity testing, includes several…
Key Takeaways from Oxford Global’s 14th Annual Biomarkers Congress
Couldn’t make the Oxford Global’s 14th Annual Biomarkers Congress? Read our recap of the key opportunities and challenges in biomarker development that scientists discussed.
Supporting a Gene Therapy Clinical Trial with Assay to Measure NAbs Against the AAV9 Serotype
Today we're featuring a case study on how BioAgilytix developed a cell-based assay to determine the prevalence of pre-existing antibodies against the AAV9 serotype in…