Empowering Precision Diagnostics
Bringing ImmunoGuide ELISA technologies to Europe and beyond
Validated ELISA kits for therapeutic drug monitoring and anti-drug antibody detection, for clinical labs, research institutions, and biotech teams. For Research Use Only.
Featured ELISA kits
Drug-level and anti-drug antibody assays across TNF-alpha, VEGF, EGFR, HER2, and more.
ADALIMUMAB ELISA
Analyte: Adalimumab
View kitADALIMUMAB ELISA (MAB-BASED)
Analyte: Adalimumab
View kitAFLIBERCEPT ELISA
Analyte: Aflibercept
View kitANTIBODY TO ADALIMUMAB ELISA
Analyte: Adalimumab
View kitANTIBODY TO BEVACIZUMAB ELISA
Analyte: Bevacizumab
View kitANTIBODY TO CERTOLIZUMAB PEGOL ELISA
Analyte: Certolizumab Pegol
View kitFrom our journal
Background on ELISA methods, therapeutic drug monitoring, anti-drug antibodies, and assay validation.
When PK Studies Slim Down, Immunogenicity Assays Carry More Weight: What FDA's 2026 Biosimilar Guidance Means for Bioanalytical Scientists
FDA's March 2026 draft guidance removes the default requirement for comparative PK bridging studies in biosimilar development, building on a prior October 2025 draft that proposed eliminating routine efficacy trials. Both actions shift evidentiary weight onto immunogenicity assays, raising the bar for ADA assay design, drug tolerance, and neutralizing antibody assessment before any clinical samples are collected.
When ADA Positivity Is Not the Answer: Rethinking the Three-Tier Immunogenicity Paradigm
The standard three-tier ADA testing paradigm has governed biologic immunogenicity assessment for more than two decades, but a growing body of evidence questions whether it consistently delivers clinically meaningful data. New publications from Immunologix Laboratories, the European Bioanalysis Forum, and IQVIA Laboratories converge on a fit-for-purpose, context-of-use-driven alternative that treats immunogenicity as a continuous biomarker endpoint rather than a binary classification.
Degevma's FDA Approval and a Market with More Than 20 Denosumab Biosimilars: What Immunogenicity Comparability Testing Actually Requires
The FDA's approval of denosumab-adet (Degevma) on September 28, 2026 brings the cumulative total of approved denosumab products to at least 20, raising a concrete methodological question: in a market this saturated, with interchangeability-driven pharmacy substitutions, what does a reported ADA incidence figure actually tell you? The answer depends entirely on whether the assay has solved the soluble RANKL interference problem, and the published literature shows that not every program has.