Sangji Kyleum Subsidiary Obtains Simultaneous CE-IVD Certification for COVID-19 Molecular and Immunodiagnostic Kits

[Asia Economy Reporter Jang Hyowon] Ace Biomed, a subsidiary of Sangji Kyleum, announced on the 23rd that it has obtained CE-IVD certification for its novel coronavirus (COVID-19) diagnostic kits, the 'RT-PCR kit' and the 'ACEBiomed COVID-19 IgMIgG' kit.

Ace Biomed's molecular diagnostic kit products are manufactured with key reagents in a lyophilized form, offering the advantage of convenient storage and use. Results can be confirmed within 50 minutes, and the kits are characterized by high sensitivity and specificity. At the same time, the immunodiagnostic kit ('ACEBiomed COVID-19 IgMIgG'), which also received CE-IVD certification, has been proven to be an excellent product with high sensitivity and specificity.

Ace Biomed obtained export approval from the Korean Ministry of Food and Drug Safety in July and August for the ultra-fast molecular diagnostic kit (Palm PCR™ COVID-19 Fast Real-time RT-PCR) and the immunodiagnostic kit 'ACEBiomed COVID-19 IgMIgG,' respectively. Subsequently, it received usage approval for the ultra-fast molecular diagnostic kit from Mexico's InDRE.

A company official stated that, in addition to this CE-IVD certification, certifications for usage approval are currently underway in North America, including the United States and Canada, as well as in Southeast Asian countries.

Furthermore, the official said, “Clinical trials are underway for the antigen diagnostic kit 'COVID-19 AG RAPID KIT,' and we expect to receive export approval for all COVID-19 related diagnostic kits within 2020.” They added, “If the development of the antigen diagnostic kit is successful, we will be able to supply customized diagnostic kits tailored to the demand of each country.”

Meanwhile, U.S. President-elect Joe Biden has shown strong determination to suppress COVID-19, including free nationwide COVID-19 testing, even before his inauguration. The globally recognized competitiveness of 'K-quarantine' is expected to be spotlighted again, accelerating the export of the company's diagnostic kits.

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