GenBody’s CEO Jin Soo Kim stated that this test requires just one to two drops of blood as a sample and takes less than 10 minutes to diagnose. As compared to the regular tests that take up to 6 hours, it can enable prompt field diagnosis and is useful for conducting tests on the body of people even in their asymptomatic stages.
The test is also economical with higher accuracy than existing rapid diagnostic kits. In the clinical tests conducted in Korea and abroad, GenBody’s diagnostic kit demonstrated 96% to 100% accuracy at antibody development stages.
The research and development so far
Genbody has been working with the Chinese Center for Disease Control and Prevention (CDC) in Jiangsu, China as well as local hospitals in Shanghai and Wuhan to conduct research and clinical trials.
The developed version of the kit received the CE certification in March, and has completed product registration and is listed on the FIND (The Foundation for Innovative New Diagnostics), an institute cooperating with the World Health Organization. Its application for FDA Emergency Use Authorization (EUA) is also underway.
“GenBody’s rapid diagnostic kit is an economic and convenient means to conduct field diagnostic tests and can contribute particularly in screening random populations with infections”, said Chom-Kyu Chong, CTO of GenBody. “Orders for our kits have been surging, and we are pulling out all efforts to meet the demand.”
GenBody develops in vivo and in vitro diagnostic tests. Since its establishment in 2012, GenBody has been exporting products to 15 countries including Brazil, China, Indonesia.
Including the rapid diagnostic kit for the Zika Virus, GenBody has developed seven of the world’s first diagnostic kits for MERS, yellow fever, Lassa fever, Mayaro fever, etc., and owns over 100 disease diagnosis technologies for hormone and metabolic diseases.
It has also developed the world’s first rapid diagnostic kit during the Zika outbreak in 2016 and as the first company in Korea, signed a supply contract with Brazil worth $35 million.
The big deal
CEO Jin Soo Kim announced that Genbody Inc. has received permission from the Ministry of Food and Drug Safety to export its rapid diagnostic kit for the novel coronavirus (COVID-19) ‘GenBody COVID-19 IgM/IgG’.
The company is currently in the final stages of export contracts and letters of intent for exporting 6.2 million test kits to 15 countries across Asia, South America, Europe, and Africa.