Export licenses issued for two types of COVID-19 PCR test kits

We are delighted to announce that our ExAmplex COVID-19 PCR 3-gene kit and ExAmplex COVID-19 PCR 3-gene Lyo kit has obtained export licenses from the Ministry of Food and Drug Safety (MFDS). Both products can simultaneously detect three specific genes of COVID-19.

In the comparative clinical evaluation conducted domestically for the approval, both products were 100% consistent in sensitivity and specificity with another company’s MFDS-approved PCR kits, demonstrating excellent performance.

The PCR test kits are the fruit of the collaboration between Boditech Med and its molecular diagnostics subsidiary Ugenecell. The products enable accurate diagnosis by simultaneously detecting three specific genes of COVID-19 with only one sample. Moreover, they come in both liquid form, which is suitable for mass testing, as well as lyophilized form, which can be used in environments that lack facilities such as freezers. This twofold provision allows us to meet varied market demand.

Furthermore, it is possible to diagnose COVID-19 infection regardless of viral mutation, as the kits detect all variants including the British, South African, Brazil, and Indian strain. Since we obtained an export license for its first COVID-19 PCR test kit in April last year, the company has supplied the product to more than 30 countries. The market expansion is ongoing, thanks to the high level of convenience and reliability of the product. 

A company official said, "we foresee the continued quarterly growth this year. Not only the sales of COVID-19-related antigen/antibody immunodiagnostic kits but those of RT-PCR products are increasing. As of the second half of this year, the supply of the COVID-19 saliva antigen test kit, which is the first of its kind to be permitted for export in Korea, will begin. The sales of these products as well as our neutralizing antibody test kit, which enables quick diagnosis of COVID-19 on the spot, will translate into significant growth in the latter half of the year.”