ABSTRACT
In February 2012 the Chinese government approved Affymetrix’s GeneChip DNA microarray system for IVD use, thereby opening the floodgate to personalized medicine into a country steeped in ancient apothecary. In March 2012 Protagen (Dortmund, Germany), a company at the forefront of high-throughput protein expression, established a collaborative effort with researchers at the University of Tubingen to develop multiplex protein assays for autoimmune and cancer diagnostics. The “omics” paradigm that was first embraced in the mid-1990s (largely through the commercialization of DNA microarray platforms) has begun its transition into clinical diagnostics. Multiplex analyses of biomarkers has gained worldwide acceptance, albeit, there is still work to be done on standardization and the establishment of guidelines for governing validation.
