Syswork Receives Formal Approval from MFDS for COVID-19 Antigen Test Kit

[Asia Economy Reporter Hyunseok Yoo] The COVID-19 antigen diagnostic kit 'MARK-B COVID-19 Ag' produced by Syswork has received formal approval from the Ministry of Food and Drug Safety.

According to Syswork on the 10th, the newly approved MARK-B COVID-19 Ag product is intended for professional use in hospitals and can provide test results within 20 minutes using samples collected with a swab from the nasopharynx. The product is characterized by significantly higher accuracy compared to existing rapid antigen diagnostic kits.

Clinical trials conducted on a total of 170 subjects at a domestic university hospital confirmed a sensitivity of 90.1% in identifying patients infected with the virus as positive, and a specificity of 99.0% in identifying uninfected healthy individuals as negative. The clinical trial used a rapid antigen diagnostic kit approved by the Ministry of Food and Drug Safety as the control group. The sensitivity of the control product was confirmed to be 56.7%. This indicates that MARK-B COVID-19 Ag has a much better ability to detect virus-infected patients compared to rapid antigen diagnostic kits.

This product applies the MARK-B biosensor platform developed by BBB, the largest shareholder of Syswork, to the COVID-19 diagnostic kit. The magnetic particles and electrochemical analysis technology applied in MARK-B actively control the fluid within the kit to accurately detect the amount of biomarkers or viruses.

A company representative stated, "This means that the accuracy, which is the essence of diagnostic kits, has reached the level of PCR products," and added, "Unlike rapid antigen diagnostic kits that are simply read visually without separate equipment, the MARK-B platform uses a dedicated analyzer device portable with one hand, enabling accurate reading."

Syswork plans to maximize the advantage of MARK-B COVID-19 Ag being easy to use compared to labor-intensive and time-consuming PCR diagnostic kits and distribute it in the domestic market. Furthermore, starting with COVID diagnostic kits, the MARK-B platform will be expanded to COVID-related products as well as severe diseases such as cancer, cardiovascular diseases, and dementia.

Meanwhile, Syswork has signed a contract manufacturing agreement with BBB. Since last year, Syswork has invested in facilities capable of producing 50 million kits annually. With BBB’s approval from the Ministry of Food and Drug Safety, they plan to actively respond to market demand.