SEOUL -- Celltrion, a leading biotech company in South Korea, has secured a deal worth about 210 billion won ($185 million) to provide Sampinute, a highly sensitive COVID-19 antigen rapid test kit that can yield results within 10 minutes, to the U.S. market following Emergency Use Authorization by the Food and Drug Administration.
The kit is a portable device to support the early detection of COVID-19 patients in clinical settings. Celltrion said in a statement on November 2 that Sampinute has acquired FDA's emergency use authorization (EUA). Prime Healthcare Distributors, a wholesale distributor based in New York, will distribute it to the U.S. market with exclusive rights.
"Based on the launch of follow-up products that are about to be developed and applied for EUA, we will make all-out efforts to maximize the effect of global COVID-19 quarantine by supplying diagnostic kits not only in the U.S. but also in countries where the spread of COVID-19 is prominent," an unnamed Celltrion official was quoted as saying.
Celltrion has partnered with BBB, a South Korean company that specializes in blood testing and lab-on-a-chip technology, to produce the antigen testing kit that provides both the speed of existing rapid diagnostic kits and the high sensitivity of molecular diagnosis so that COVID-19 patients can be sorted out in the early stages of infection.
The real-time polymerase chain reaction (RT-PCR) method that amplifies specific DNA samples and takes at least six hours to get results has been used widely in South Korea due to its reliability. Celltrion insists its method showed a high sensitivity of 94 percent compared to RT-PCR, making it the highest level of completion among existing rapid diagnostic kits.
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