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

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

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

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Launched in US

company h anunced its plans to expand its diagstic portfolio for SARS-CoV-2 in early July to curb COVID-19 infections. Furr, it said that it h initiated its efforts to improve access to COVID-19 testing for people and help prevent furr spre of coronavirus.  biopharmaceutical company hequartered in Incheon, South Korea, Celltrion recently launched testing kit even in United States calling it a great market with respect to demand as US recorded a surge in its new COVID-19 confirmed cases. 

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

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