Humasis Obtains Domestic Approval for COVID-19 Molecular Diagnostic Kit

"Applicable to Most Diagnostic Devices on the Market"

[Asia Economy Reporter Myunghwan Lee] Humasis announced on the 29th that it has obtained domestic approval for the COVID-19 molecular diagnostic kit developed this year in preparation for the post-COVID-19 era.

Humasis explained that on the 27th, it acquired the manufacturing license for the COVID-19 molecular diagnostic kit, 'Humasis COVID-19 RT-PCR Kit,' from the Ministry of Food and Drug Safety and completed domestic approval registration.

The time to obtain diagnostic test results with this product is approximately 51 minutes. Humasis added that the kit targets three genes to diagnose infection, enabling more accurate diagnosis.

The diagnostic kit can be used with equipment such as Bio-Rad's 'CFX96 Real-Time PCR' and Thermo Fisher Scientific's 'QuantStudio 5 Real-Time PCR.'

A Humasis official stated, "'Humasis COVID-19 RT-PCR Kit' received a suitability judgment through the review of in vitro diagnostic medical device technical documents by the Ministry of Food and Drug Safety, and with this domestic registration, it can now be officially marketed in the domestic market. We will continue to do our best to establish new growth engines by not being satisfied with the present and by continuously investing in the company's conditions and technology development to expand new technologies and product lineups."

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