Sugentech Establishes Allergy Testing Solution Covering 239 Allergens

Global in vitro diagnostics company Sugentech has established a solution for testing the largest number of allergens in South Korea, covering 239 types.

Sugentech announced on October 29 that it had obtained domestic regulatory approval for its new allergy diagnostic product, 'SGTi-Allergy PLUS 120.'

The newly approved product can test for up to 239 allergens when used in conjunction with the existing 'SGTi-Allergy Screen PLUS.' It can screen for a broad range of allergens encountered in South Korea and overseas, including inhalant, environmental, and food allergens. Analysis of 45 component allergens also enables more detailed assessment of allergy sensitization.

Sugentech plans to use this foundation to pursue the European market. The company is seeking CE certification under the European In Vitro Diagnostic Medical Devices Regulation (IVDR) and expects to obtain approval by the end of the year. It plans to use this as a springboard to register its products in major European countries and expand its local distribution network, strengthening its export competitiveness in the global allergy diagnostics market.

A Sugentech representative said, "This approval for our new product will be an important milestone in expanding our allergy diagnostics business, backed by the broadest testing coverage in South Korea at 239 allergens and our in-house expertise in developing instruments and reagents. We will expand supply to major clinical laboratories and large hospitals in South Korea, and accelerate global business growth in 2027 by leveraging our business experience in overseas markets, including Asia and Africa, as well as our anticipated IVDR approval in Europe by the end of this year."

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