IVD And CDx Solutions: Comprehensive Services From Research To Regulatory

Developing successful diagnostics is a complex journey, demanding not only scientific expertise but also the ability to skillfully navigate global regulatory frameworks and conduct effective clinical trials, especially for novel or high-risk products. A comprehensive partner can bring together a robust biobank of biospecimens with essential services like biomarker and assay development, clinical trial support, and regulatory guidance to help turn a diagnostic from research into a reality.

Solutions for IVD and CDx development span the entire lifecycle, from early-phase biomarker discovery through clinical trial assay development and full IVD development. This includes access to a vast biobank, with millions of liquid and tissue biospecimens covering over 90 medical conditions. Support services include kitting and logistics , running prospective collections at 150+ clinical sites , and providing regulatory expertise for submissions like IDEs, 510(k)s, PMAs, and Annex XIV. Discover the full scope of end-to-end solutions for your IVD and CDx development.