EntroGen participated in the 16th World Clinical Biomarkers & Companion Diagnostics Summit, held October 5–8 in Boston, bringing together leaders in pharmaceutical development, diagnostics, and precision medicine.
Matthew Maland, Director of Regulatory Affairs at EntroGen, presented “Roadmap for Global Clinical Trial Assays: Leveraging Distributor Kits for CDx Success.” His presentation explored how established commercial in vitro diagnostic (IVD) kits can provide a starting point for clinical trial testing while preserving options for future companion diagnostic (CDx) development.
Building on What Already Exists
As drug programs advance, clinical trial testing requirements evolve. Established diagnostic kits may offer existing validation, manufacturing controls, documentation, and regulatory experience, although additional work may be needed to meet trial-specific and regional requirements.
Maland outlined an approach to identifying what is already in place and which gaps must be addressed, helping sponsors and diagnostic partners focus resources on current needs without committing prematurely to a broader CDx program.
The presentation also examined the operational requirements of deploying assays across multiple laboratories and regions, including site qualification, training, quality control, logistics, documentation, and coordination among sponsors, diagnostic manufacturers, and testing laboratories.
Creating a Path Toward CDx Development
Well-planned clinical trial assay programs can create value beyond the immediate study by building operational experience, evidence, laboratory relationships, and infrastructure that may support subsequent development.
The objective is to meet current trial requirements while preserving a practical path forward as a drug program evolves. By assessing existing capabilities and addressing the gaps that matter, sponsors and diagnostic partners can build a roadmap aligned with both immediate needs and longer-term goals.
Through its participation in World CDx 2026, EntroGen shared its perspective on clinical trial assay deployment and the evolving path from trial testing to companion diagnostic development.
About EntroGen
Founded in 2007, EntroGen develops and manufactures molecular diagnostic products for oncology and hematology, including PCR-based assays, reagents, and supporting software. The company works with laboratories and distribution partners internationally to support molecular testing workflows and diagnostic development initiatives.