19 June 2020 | News
The test has already received US FDA's Emergency Use Authorization (EUA)
South Korea's Yuyu Pharma and SD BIOSENSOR entered into a Supply Agreement, where Yuyu Pharma will export COVID-19 Test Kits to the Global Market. Leveraging Yuyu Pharma's global network, the company is in talks with several healthcare providers and leading hospitals to export the COVID-19 kits.
US FDA gave Emergency Use Authorization (EUA) to STANDARD M nCoV Real-Time Detection Kit made by SD BIOSENSOR back in April 23, 2020. With the EUA, SD BIOSENSOR has the authority to supply STANDARD M nCoV Real-Time Detection Kit across the US. STANDARD M nCoV Real-Time Detection Kit is used for rapid identification and detection of novel coronavirus (2019-nCoV) nucleic acids in human nasopharyngeal swabs and throat swab samples. This is RT-PCR test that amplifies and diagnoses a specific gene sequence of COVID-19.
Federal Emergency Management Agency (FEMA), an agency within the US Department of Homeland Security, has already purchased $5.2 million USD of SD Biosensor's test kits back in April 2020.
Hyo-Keun, Lee CEO of SD BIOSENSOR said that "We have been providing quality kits since 2010. Our HIV, Malaria and Syphilis test kits are already on the World Health Organization (WHO) list of prequalified in vitro diagnostic products. And we are proud to know that our COVID-19 kits will help facilitate in the fight against the spread of the coronavirus and possibly save lives. We will continue to provide quality products to help improve the health of all people around the world"
Robert Yu, CEO of Yuyu Pharma, said that "The partnership with SD BIOSENSOR will help provide much needed COVID-19 Kits to medical professionals. We hope our efforts will contribute in the fight against the coronavirus."