ABSTRACT
Companion diagnostics (CDx) are essential to the practice of precision medicine. Next-generation sequencing is an increasingly important tool in the development of CDx. However, for CDx to be deployed, many different biopharma industry sectors need to collaborate. This paper outlines some of the challenges and opportunities perceived by the biopharmaceutical industry, the Europe Molecular Quality Network, a regulatory agency, a notified body and a CDx service provider.
Subject(s)
Diagnostic Test Approval/legislation & jurisprudence , Diagnostic Tests, Routine/standards , Government Regulation , High-Throughput Nucleotide Sequencing/standards , Precision Medicine/methods , Biopharmaceutics/legislation & jurisprudence , Biopharmaceutics/methods , Biopharmaceutics/trends , Diagnostic Tests, Routine/trends , European Union , Molecular Diagnostic Techniques/methods , Molecular Diagnostic Techniques/trends , Precision Medicine/trendsABSTRACT
Congenica (Cambridge, UK) is a world leading developer of genome-based discovery and diagnostic technologies. The UK company is a spin-out from the Wellcome Trust Sanger Institute (Cambridge, UK) and was founded by scientists and clinicians at the leading edge of genomic analysis. Congenica's Sapientia™ technology platform allows whole-genome sequence analysis to be easily interpreted and presented within a clinically actionable diagnostic report. It is based on pioneering research from Wellcome Trust Sanger Institute, National Health Service clinicians and regional genetic testing laboratories and validated by Genomics England Ltd (London, UK). Sapientia used for medical diagnosis in hospitals including Great Ormond Street Hospital (London, UK), Manchester Centre for Genomic Medicine (Manchester, UK), Birmingham Women's Hospital (Birmingham, UK) and for new drug development by pharmaceutical companies. This profile follows the journey from proof of concept to clinical diagnosis.
