PHC Receives Conditional Approval for COVID-19 Rapid Antigen Test Kit in South Korea

[Asia Economy Reporter Jang Hyowon] PHC announced on the 26th that its affiliate, Philosis, has obtained conditional domestic manufacturing approval from the Ministry of Food and Drug Safety for the novel coronavirus infection (COVID-19) rapid antigen diagnostic kit ‘Gmate Covid-19 Ag’ and will begin domestic sales. The approved product uses a rapid diagnostic method and is currently in use in multiple countries overseas, including Malaysia.

PHC has recently expanded its sales channels in the global market by obtaining approval for rapid diagnostic kits in several countries such as Thailand, Germany, and Russia. With the recent conditional approval from the Korean Ministry of Food and Drug Safety, the company’s excellent diagnostic technology for COVID-19 has been recognized both domestically and internationally.

This conditional approval was granted because Philosis currently holds GMP (Good Manufacturing Practice for medical devices) certification only for its existing blood glucose meters and does not yet have GMP certification for rapid diagnostic kits. According to the company, the review for this is currently underway.

A PHC representative stated, “This conditional approval is equivalent to domestic approval, and the company only needs to submit the GMP certificate by 2024.” They added, “Since both the existing blood glucose meters and rapid diagnostic kits are Class 3 medical devices and the company holds multiple overseas approvals, we expect the process to be completed smoothly.”

Meanwhile, PHC is releasing a variety of COVID-19 diagnostic product lines, including neutralizing antibody diagnostic kits that can determine whether antibodies have been generated after COVID-19 infection, in addition to rapid antigen diagnostic kits.

Recently, as the risk of spread of the COVID-19 Omicron variant is rapidly increasing domestically, the government and local governments are planning to utilize rapid diagnostic kits, and health insurance coverage for rapid antigen tests at hospitals and clinics is also under review. Furthermore, depending on whether Omicron becomes dominant, it is known that the COVID-19 diagnostic testing method will shift from being PCR-centered to an expansion of rapid antigen testing.