Quality Requirements and Standards
Will Molecular Diagnostics repeat our QC mistakes?
Molecular diagnostics is a field exploding with growth. Next Generation Sequencing (NGS), RNA and DNA microarrays, mass spectrophotometry are poised to enter the clinical laboratory. Special challenges arise when we try to apply "traditional" quality control and quality assurance models to these new testing technologies. Not only will we need to adapt current quality thinking to the practical realities of the new tests - we will definitely need to avoid repeating the mistakes we made in our traditional QC approaches.