South Korea's Celltrion gets US FDA authorisation for COVID-19 test kit

On October 25, Korean pharmaceutical firm Celltrion announced in a press release that it has received approval for emergency use by the US Food and Drug Administration (FDA) for its Corona 19 Rapid Diagnosis Antigen Kit’ Sampinute’. According to the company, the kit provides the on-site diagnosis (POCT, Point of Care Testing) that has an enhanced sensitivity of 94 percent and takes an estimated 10 minutes to test for the coronavirus. 

Testing kit, Sampinute  “incorporates proprietary Corona 19 antibody-antigen technology, and allows you to check the results in 10 minutes using a portable professional equipment,” the firm informed in a statement, adding, that it was developed by the domestic manufacturers. The approval of the kit was given nearly three months after the company requested the USFDA for approval in late July. Promising better and more accurate results compared to the existing RT-PCR (reverse transcription-polymerase chain reaction) method, the firm said, " This product uses portable equipment at the clinic site that enables specimen testing and results in confirmation with the highest level of sensitivity among rapid diagnostic devices.”

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Launched in the US

The company had announced its plans to expand its diagnostic portfolio for SARS-CoV-2 in early July to curb the COVID-19 infections. Further, it said that it had initiated its efforts to improve access to COVID-19 testing for the people and help prevent the further spread of coronavirus. The biopharmaceutical company headquartered in Incheon, South Korea, Celltrion recently launched the testing kit even in the United States calling it a great market with respect to demand as the US recorded a surge in its new COVID-19 confirmed cases. 

“Celltrion is planning to supply kits to all over the United States through local specialized wholesalers,” the firm revealed in the release. Furthermore, an official from Celltrion said, "Currently, the demand for rapid diagnosis antigen kits in workplaces, schools, and institutions in the US is analyzed to be high. And, I will do my best to contribute to the end of the global virus.” Meanwhile, according to a report released by the market research organization Grand View Research, the global diagnostic device market is expected to hit $ 19.8 billion by end of 2020, about 22 trillion KRW.

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