SugenTech Receives European CE Certification for COVID-19 Neutralizing Antibody Test Kit... "Expecting Benefits from Vaccination"

[Asia Economy Reporter Hyunseok Yoo] SuzenTech announced on the 29th that its COVID-19 neutralizing antibody test kit has received European CE certification. Since the neutralizing antibody test kit is used to determine whether immunity has been generated in COVID-19 vaccine recipients, the company expects related demand to increase as vaccination rates rise.

SuzenTech is the second company worldwide to successfully develop a quantitative neutralizing antibody test kit. With this approval, the company can sell the neutralizing antibody diagnostic kit in major countries around the world that use the European CE certification.

SuzenTech's COVID-19 quantitative neutralizing antibody test kit, ‘SGT SARS-CoV-2 In Vitro Neutralizing Antibody Test (IVnAT),’ identifies whether ‘neutralizing antibodies’?which neutralize the virus's cell penetration?have been formed among the antibodies generated in an infected person's body. It can quantify not only the presence of neutralizing antibodies but also the percentage (%) and level of specific antibodies that can neutralize COVID-19 infection to some extent, enabling rapid assessment of vaccine effectiveness.

According to ‘Our World in Data,’ a statistics-focused site operated by the University of Oxford in the UK (as of the 27th local time), 80 million people worldwide have completed COVID-19 vaccination. Since most COVID-19 vaccines, except Janssen (Johnson & Johnson), require two doses, the frequency of antibody formation checks is expected to increase, leading to higher demand for neutralizing antibody kits as vaccination accelerates.

A SuzenTech official stated, “SuzenTech's neutralizing antibody diagnostic kit measures the amount of neutralizing antibodies using the enzyme-linked immunosorbent assay (ELISA) method, offering advantages such as shorter reaction times and the ability to analyze large numbers of samples compared to existing products,” adding, “It can be used in general hospitals, screening centers, research institutes, and companies developing vaccines and antibody therapeutics.”

He continued, “Based on this European certification, we plan to actively market in Europe, including Germany, and are also pursuing FDA EUA approval to enter the U.S. market,” adding, “As vaccination rates increase and therapeutic development accelerates, the neutralizing antibody testing market is gradually expanding, making this certification highly significant.”

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