[MONEYTODAY] Median Diagnostics, obtaining a Certificate of Free Sales in abroad for COVID-19 Antigen Rapid Kit

  • Date : 2020.11.19 13:35
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SARS-CoV-2 Antigen Rapid Kit (Product name : MDx COVID-19 Ag Rapid Test)


Median Diagnostics (CEO, Oh Jin-sik), a company specializing in diagnostic kits, announced it on the 16th that Median recently obtained a Certificate of Free Sales in abroad for COVID-19 Antigen Rapid kit (Product name : MDx COVID-19 Ag Rapid Test) from the Ministry of Food and Drug Safety in Korea.


The kit is an immuno-diagnostic reagent that detects viruses using specific antibodies to the COVID-19 virus.


According to the company, actual clinical evaluations showed a matching rate of over 95 percent in majority of patients with clinical symptoms. The test takes about 15 to 20 minutes. The company said, "It could be used properly in situations in which a virus spreads on a large scale, or an explosion of infections or in areas where PCR test is difficult.".


"Our COVID-19 Antigen Rapid kit is able to detect live viruses (SARS-CoV-2) more sensitively than existing antigen immuno-diagnostic reagents in the market now," said Oh Jin-sik, CEO of Median Diagnostics. "We will apply for approval of antigen diagnostic kit and antibody diagnostic kit to the U.S. Food and Drug Administration (FDA)."

He added, "Because we produce raw materials on our own, we will be able to gain an upper hand not only in performance but also in price competitiveness".


*Source : https://news.mt.co.kr/mtview.php?no=2020111611574475894