PHC Obtains Australian Approval for 'COVID-19 Diagnostic Kit' Sales

[Asia Economy Reporter Jang Hyowon] Philosis, an affiliate of PHC (CEO Choi Inhwan), announced on the 14th that it has received approval from the Australian TGA (Therapeutic Goods Administration) to sell its COVID-19 rapid diagnostic product for self-testing.

The Australian TGA has allowed the sale of rapid diagnostic kits for self-testing in the domestic market since November last year. With this, PHC became the second domestic company, following SD Biosensor, to obtain approval for selling COVID rapid antigen kits for self-testing.

The newly approved product, 'Gmate COVID-19 Ag,' uses a saliva-based diagnostic method with a sensitivity performance of over 95% and offers management through an app. The saliva-based method minimizes discomfort for the test subject compared to the conventional nasopharyngeal swab method, reduces the risk of infection, and allows the test subject to easily collect and verify the sample without the help of medical professionals.

A PHC official stated, "Approval from the Australian TGA is very stringent, along with approvals from the US FDA, European CE, and Japan's Ministry of Health, Labour and Welfare, making it difficult to obtain. However, the rapid diagnostic kit product approved this time was registered with the highest performance level of 'Very High Sensitivity' among the TGA's self-test product performance stages." He added, "By receiving this TGA approval, the product's performance and quality system have been recognized to the extent that approval procedures can be simplified when entering other countries."

PHC recently obtained conditional approval domestically and has also received self-diagnostic kit approvals and expanded exports in countries such as Argentina, Brunei, Malaysia, Austria, and Colombia. With this Australian TGA approval, the company expects to expand its market share in the global market.

This content was produced with the assistance of AI translation services.