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Integrated companion diagnostics development and manufacturing. Diagnostics expertise from biomarker validation through FDA approval and commercial launch.
Companion diagnostics (CDx) represent one of the most technically and regulatorily complex pathways in the diagnostic industry. The coordination required between drug development programmes, diagnostic validation, and parallel regulatory submissions creates challenges that few companion diagnostics CDMOs are equipped to navigate successfully.
Abingdon Health specialises in moving companion diagnostic projects from initial biomarker concepts through FDA approval and commercial manufacturing. Our integrated approach as an in vitro diagnostics development partner addresses the unique complexities of CDx development, where technical performance, regulatory strategy, and manufacturing scalability must advance in parallel from day one.
Lateral flow is not always the right answer for a CDx claim. Where a programme needs quantitative results or a nucleic acid target, we assess molecular and reader-based formats in parallel during feasibility.
