We are excited to share that AFIAS COVID-19 Ag has obtained EUA (Emergency Use Approval) from Japan PDMA (Pharmaceuticals and Medical Devices Agency). It can diagnose the SARS CoV-2 virus within 12 minutes. The EUA of the Japanese PMDA for the Boditech Med’s AFIAS COVID-19 Ag is the result of three clinical tests for analytical and clinical performance, which is equivalent to the recognition of our technology in the Japanese market which is very sensitive to quality.
In the process of preparing for the Tokyo Olympics, Japan is actively responding to the COVID-19, with nearly 2,000 confirmed cases per day. Boditech Med is now actively promoting with local partners so that it can be used for infection control during the Olympic Games.
This approval has a symbolic meaning as it is the first approval for EUA in Japan among COVID-19-related products of Boditech Med which is expected to greatly help in enhancing the brand value of Boditech Med as well as increasing its share in the POCT market in Japan.
As the approval of the antigen diagnostic kit has been completed, Boditech Med is also in the process of launching a neutralizing antibody diagnostic test in the Japanese market. The neutralizing antibody diagnostic test is a product that can immediately determine the activity of neutralizing antibodies within 20 minutes after inoculation, regardless of the type of vaccine. After the Olympics, this neutralization antibody test can be widely used in the stage when the vaccination rate in Japan has improved to a level where herd immunity can be expected, and economic activities in Japan are normalized and foreign tourists are actively inflowing.
A company official said, “This approval is expected to serve as a cornerstone for entry into the POCT market in Japan, which is growing steadily with an annual value of 450 billion won. To this end, approval for use of cardiovascular disease-related diagnostic kits, which have significant strength in on-site diagnostics, is also in progress, in addition to COVID-19 related products. Boditech Med already completed approval of D-Dimer products for diagnosing deep vein thrombosis (DVT) and pulmonary embolism (PE) in February, and cardiovascular diseases such as Tn-I Plus, NT-proBNP, CK-MB, and Myoglobin Approval of a representative diagnostic product for the disease is in progress.”