Sujentec Completes Domestic Manufacturing Certification from MFDS for 'Type 1 Diabetes Diagnostic Reagent'
[Asia Economy Reporter Lee Gwan-joo] SuzenTech announced on the 15th that it has completed domestic manufacturing certification from the Ministry of Food and Drug Safety for its Type 1 Diabetes Diagnostic Reagent (SGTi-T1D Anti-GAD).
The approved product is a reagent that qualitatively measures autoantibodies (Anti-GAD) against glutamic acid decarboxylase in human serum using an enzyme immunoblotting assay to diagnose Type 1 diabetes, and it can be diagnosed through the company's multiplex immunoblotting device (S-BLOT2).
SuzenTech explained that since its multiplex immunoblotting device (S-BLOT2) and diagnostic reagent (SGTi-T1D Anti-GAD) perform automated enzyme immunoassays, they have the advantage of being widely usable in general laboratories compared to the conventional radioimmunoassay method that uses radioactive isotopes.
A SuzenTech official stated, “Due to COVID-19, diagnostic demand has arisen not only for respiratory diseases but also for various other illnesses,” adding, “Based on our advanced antibody development technology and highly sensitive and precise immunoassay methods, we will expand our items for autoimmune diseases including diabetes, allergies, and Alzheimer's.”
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Meanwhile, SuzenTech was the first in the world to develop a multiplex immunoblotting device (S-BLOT3) and reagent (SGTi-Allergy screen) that diagnose over 100 allergies at once. Having secured European CE certification, the company plans to officially enter the Chinese market in 2022 through its local partner (YHLO).
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