Point-of-care molecular diagnostic devices are a rapidly expanding market. A variety of technologies are being developed for DNA detection and amplification, mostly aiming to detect pathogens. Of the two devices for detection of human genetic variations, both focus on CYP2C19 and have obtained regulatory approval. Most other devices have not obtained US FDA approval and are still undergoing clinical trials. Most, if not all, devices in development require equipment to which disposable test cartridges are placed. Thus, they may not fulfill FDA's definition of being 'simple'. There is a clear need to develop completely disposable devices that do not require equipment maintenance, and to detect other genetic variants predictive of disease susceptibility and drug response.
Keywords: Atlas io™; Gene Z; Nanomix; Nanosphere Verigene®; QuantuMDx Q-POC™; SNP Dr; Spartan; molecular diagnosis; point-of-care.