Humasis Registers COVID-19 Antibody Test Kit with US FDA

[Asia Economy Reporter Hyunseok Yoo] Humasis, a multi-quantitative in vitro diagnostic specialist company, has registered its novel coronavirus (COVID-19) antibody test kit with the U.S. Food and Drug Administration (FDA), enabling supply within the United States.

Humasis announced on the 23rd that its antibody test kit, ‘Humasis COVID-19 IgG/IgM Test,’ was registered with the FDA on the 20th.

There are two ways to supply novel coronavirus diagnostic products in the U.S.: product registration with the FDA (NOTIFICATION PATH) or obtaining Emergency Use Authorization (EUA PATH). RT-PCR diagnostic reagents, used as the definitive method for COVID-19 diagnosis, require EUA for standalone diagnosis. In contrast, antibody test kits can be supplied in the U.S. through product registration alone.

Humasis’s product is an antibody test kit that diagnoses antibodies formed in response to viruses that have penetrated the body. Through this product registration, the company can quickly meet demand within the U.S. Since last month, when the COVID-19 situation in the U.S. worsened, Humasis has received supply requests from numerous U.S. companies. Currently, contract negotiations for product supply are underway with medical institutions in New York, Pennsylvania, Florida, Texas, and California, and the recent FDA product registration is expected to accelerate these negotiations.

Previously, the company signed multiple overseas export contracts and has been supplying products, including a contract to supply 500,000 COVID-19 antibody tests with the Embassy of India in Korea and the first domestic brand supply contract in the S?o Paulo region of Brazil. Countries where contracts and sales are already underway include Brazil, Germany, the United Kingdom, France, and 30 other countries, with approximately 3 million tests supplied overseas.

The company plans to proceed sequentially with contracts and deliveries in the U.S. according to the delivery schedules of other countries where contracts have been signed. Cha Jung-hak, CEO of Humasis, stated, “We are in export negotiations with five U.S. state governments, and with product registration completed, the likelihood of contract success is increasing. We are currently operating the factory at maximum production capacity to ensure smooth delivery, and since the products already shipped have been recognized for their performance locally, we are preparing for additional volume requests.”