Humasis, a Korean in-vitro diagnostic company, said Thursday that its Humasis COVID-19 IgG/IgM Test, an antibody test kit, has been registered with the U.S. Food and Drug Administration.
With the FDA’s nod, Hamasis can now export its diagnostic kits to the United States, the company said.
|Humasis’ antibody diagnostic kit for the new coronavirus|
There are two ways for foreign firms to provide new coronavirus-related test kits to the United States – either register their products with the FDA using “notification path,” or winning the regulator’s nod through “EUA (emergency use approval) path,” as were the cases with various diagnostics kits for Covid-19.
In the case of test kits for confirming the Covid-19 virus using reverse transcription-polymerase chain reaction (RT-PCR) agents, they have to use the EUA path. Unlike them, antibody test kits like that of Humasis can acquire sales rights by just registration with the FDA.
Humasis COVID-19 IgG/IgM Test is an antibody diagnostic kit that detects antibodies formed in response to a virus that has infiltrated the body. Through the recent registration, the company expects to meet the U.S. demand rapidly.
It has been receiving many requests from the U.S. companies since March when America began to see explosive growth in new cases. The company is negotiating with medical institutions in various U.S. states, including New York, Pennsylvania, Florida, Texas, and California. The product registration with FDA will likely speed up such processes, it added.
Outside of the U.S., the company has been contracting or planning to do so to supply about 3 million test kits with various countries, including Brazil, Germany, the U.K., and France, it said.
“We are operating the factory at full to deliver without a hitch, as our exports have won recognition for their excellent efficacy, Humasis CEO Cha Jeong-hak said.
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