Sysmex Corporation (Kobe, Japan) announced it has obtained the first marketing approval in Japan for an in vitro diagnostic medical device, a testing kit for the novel coronavirus (2019-nCoV Fluorescence Detection Real-Time RT-PCR Kit).
The company subsequently filed a change request, which was approved June 2, additionally including saliva as a sample type. The company says that, compared with the previous method of sampling mucus from deep in the nose and throat, the taking of saliva samples is expected to be a safer, faster and simpler way to conduct PCR tests for the novel coronavirus.