IVD PRODUCT CO-DEVELOPMENT
Companion diagnostics co-development
Molecular monitoring of patients with companion diagnostics to guide therapies and understand disease activity are valuable tools in the improvement of patient care. Through discovery, refinement and validation of genomic signatures, DxTerity® provides a full suite of in-vitro diagnostic (IVD) product development services in accordance with US FDA Design Control and CE-IVD requirements.
Expert Design Control to Simplify Product Roadmap
Developing robust products under design control necessitates a strong understanding of requirements for product definition, risk analysis, transfer to manufacturing and validation, as well as the clinical and regulatory review process. DxTerity’s experienced design and development team has taken multiple tests from concept through to FDA clearance. We use a “phase‐gated” design process that ensures product requirements are clearly defined and met.
Smooth Transition to GMP Manufacturing
DxTerity understands both the materials and manufacturing processes for molecular IVD products and has extensive experience in guiding transfer to cGMP (current Good Manufacturing Practice) in compliance with industry and regulatory standards. DxTerity manages an integrated supplier base under cGMP and ISO 13485, supporting both branded and white label manufacturing to custom specifications.