PHC Obtains Domestic IRB Approval for Saliva-Based COVID-19 Diagnostic Kit

[Asia Economy Reporter Jang Hyowon] Philosis, an affiliate of PHC (CEO Choi Inhwan), announced on the 29th that it has obtained approval from the Institutional Review Board (IRB) of the Catholic University Eunpyeong St. Mary's Hospital, a domestic clinical trial institution, for its saliva-based COVID-19 antibody rapid diagnostic kit (Gmate COVID-19 Ag Saliva).

PHC plans to apply for domestic approval based on the ongoing clinical trial results, and with the recent rapid spread of the Omicron variant and its subvariant (BA.2) in Korea, as well as the increasing market demand for saliva diagnostic kits domestically, related approval is expected to be granted soon.

Philosis's saliva-based COVID-19 antibody rapid diagnostic kit has received authorization from the U.S. Food and Drug Administration (FDA), European CE certification, Japan’s Ministry of Health, Labour and Welfare, and the Australian Therapeutic Goods Administration (TGA), which applies some of the strictest regulations. In particular, the Australian TGA has evaluated its performance as superior, with sensitivity higher than some PCR (polymerase chain reaction) diagnostic kits.

A company representative stated, “We are actively proceeding with the requirements for domestic approval, and under the current circumstances, the approval process by the Ministry of Food and Drug Safety is expected to proceed quickly, so sales are anticipated to be possible soon. The convenient self-diagnostic method using saliva can be widely used not only by young students but also by general companies and government offices.”