Sugentech completes FDA registration to export superfast COVID test kit to US

2020.04.06 15:12:16 | 2020.04.06 16:00:59

[Photo provided by Sugentech]이미지 확대

[Photo provided by Sugentech]

Sugentech, a South Korean medical diagnostics company, is scaling up production of its antibody-based testing kit for COVID-19 after its product registration with the U.S. Food and Drug Administration was successfully completed last week, the company’s chief executive Sohn Mi-jin said.

“We are rushing to expand facilities to meet mounting demand from overseas markets including the U.S. with a goal of shipping 400,000 tests per week from the middle of this month and 1 million tests from May,” said Sohn during an interview with Maeil Business Newspaper last weekend.

Shares of Kosdaq-listed Sugentech gained 15.25 percent to finish Monday at 29,100 won ($23.68).

The company received approval from Korean health authorities late last month to sell its fast testing kit overseas and shipment has been underway for European countries under CE-IVD certification.

To export Korean-made COVID-19 testing kits to the U.S., the manufacturer can either go through the FDA’s Emergency Use Authorization (EUA) process or register its product with the FDA and receive an order from a state government for shipment to the state.

이미지 확대
Sugentech is one of the only two Korean IVD firms whose testing kit for COVID-19 has been registered with the FDA. Some 20 products from China recently lost their registration status due to quality issues.

Sugentech’s fast testing kit `SGTi-flex COVID-19 IgG/IgM` is a gold nanoparticle-based immunochromatographic test kit for qualitative determination of COVID-19`s IgM and IgG antibodies in human whole blood, serum or plasma. Because it is a test method that uses a blood sample, the sampling risk is not high, as in the molecular diagnostic method (RT-PCR). This method can detect infection within 10 minutes with the naked eye without a trained analyzer or analysis equipment.

“A large-scale clinical trial with 250 specimens at a Daegu hospital showed that the diagnostic accuracy reached 94.4 percent, close to that of RT-PCR,” said Sohn, downplaying claims the antibody-based testing is less accurate than RT-PCR. “Since RT-PCR has its own limitations, it is essential to perform an antibody test in parallel for COVID-19 testing,” she said.

As the RT-PCR assay amplifies nucleic acids from samples for testing, it is possible to accurately detect and analyze even the smallest amount of COVID-19. However, if the sample is not extracted properly, it is simply useless. Particularly in the case of asymptomatic patients, RT-PCR can cause errors in diagnosis because it is not easy to extract virus DNA from the patient. “This is why China, the U.S. and the World Health Organization recommend and antibody testing in addition to as RT-PCR to increase accuracy,” Sohn explained.

[Photo provided by Sugentech]이미지 확대

[Photo provided by Sugentech]

“Diagnostic products have been undervalued compared to pharmaceuticals, but their importance and value draw renewed attention amid COVID-19 pandemic,” said the former researcher at state-funded Korea Research Institute of Bioscience and Biotechnology.

Sugentech was co-founded in 2011 by Sohn and her two colleagues who worked at LG Life Sciences’s diagnostic research lab. With the acquisition of KMAC Bio Center, then the leader in diagnostic equipment in 2017, Sugentech became an unusual IVD player that has both diagnostic kit and diagnostic equipment technology in Korea. Currently, it has about 100 employees, including 50 researchers.

By Kim Si-gyun and Minu Kim

[ⓒ Pulse by Maeil Business Newspaper & mk.co.kr, All rights reserved]