In Vitro Diagnostics for SARS-CoV-2 Infection Authorized in the United States and Approved in Japan

In vitro diagnostics (IVDs) for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) played a critical role in the early detection and management of infection, yet regional disparities in their availability remain underexamined. We retrospectively analyzed molecular and antigen IVDs for SARS-CoV-2 authorized by the U.S. Food and Drug Administration (FDA) and approved by the Pharmaceuticals and Medical Devices Agency (PMDA)/Ministry of Health, Labour, and Welfare (MHLW) in Japan between 2020 and 2023, using publicly available data. The FDA granted Emergency Use Authorization (EUA) to 373 IVDs (302 molecular and 71 antigen), while the PMDA/MHLW approved 153 IVDs (55 molecular and 98 antigen) under the Priority Review system within the regular approval framework. In the United States (US), authorizations surged in early 2020, whereas in Japan, approvals increased more gradually until mid-2021. Real-time polymerase chain reaction and lateral flow immunoassay were the predominant methods for molecular and antigen tests, respectively, in both countries. In Japan, 71% of prescription-only IVDs were developed by domestic companies, compared with 79% in the US. In summary, a greater number of IVDs for SARS-CoV-2 were authorized in the US than were approved in Japan, particularly early in the pandemic. The EUA system in the US facilitated the rapid authorization of IVDs. Japan's Priority Review system enabled rapid approvals, while the newly introduced Emergency Approval system-although not applied to IVDs for SARS-CoV-2-may enable more timely approval and distribution of IVDs in future public health emergencies.