Sangji Kyleum Subsidiary Ace Biomed Receives Mexico Approval for COVID-19 Diagnostic Kit

Passed 'InDRE' Standard with Excellent Sensitivity... Expected to Enter South American Market
Aiming to Complete Development and Production of COVID-19 Antigen Test Kit Within the Year

[Asia Economy Reporter Jang Hyowon] Ace Biomed, a subsidiary of Kosdaq-listed company Sangji Kyleum, announced on the 22nd that it has obtained approval for the use of its ultra-fast COVID-19 molecular diagnostic kit, ‘Palm PCR™ COVID-19 Fast Real-time RT-PCR Kit,’ from ‘InDRE,’ the Mexican equivalent of the Food and Drug Administration.

Ace Biomed had previously obtained export approval for the ultra-fast COVID-19 molecular diagnostic kit from the Korean Ministry of Food and Drug Safety in July. With the recent approval for use in Mexico, the company is raising expectations for exports to the South American region.

The product is a Real-time RT-PCR kit that measures the amount of PCR amplification product in real time, delivering results within 50 minutes, and is characterized by high sensitivity and specificity. In particular, it passed the clinical specimen test conducted by Mexico’s ‘InDRE’ with excellent sensitivity, reaffirming the superiority of the company’s technology.

Currently, the cumulative number of COVID-19 confirmed cases worldwide is approximately 30.66 million, with the United States having the highest number at about 6.72 million, and Mexico ranking seventh with about 690,000 confirmed cases.

A company official stated, “With this approval, it has become possible to export the company’s ultra-fast COVID-19 kit to Mexico,” adding, “The company is currently undergoing certification for use approval in North America, including the United States and Canada, as well as Europe.”

Additionally, Ace Biomed is independently developing an antigen diagnostic kit, ‘COVID-19 AG RAPID KIT,’ and plans to complete the development and production of all COVID-19 related diagnostic kits within this year. If the development of the antigen diagnostic kit is successful, the company expects to improve its market share in COVID-19 diagnostic kits by supplying customized diagnostic kits tailored to the demand of each country.