SeaSun Biomaterials announced on the 4th that 'U-TOP SARS-CoV-2 & Flu A/B', which can diagnose COVID-19 and flu virus at once, has received export permission from the Ministry of Food and Drug Safety.

Currently, 'U-TOP SARS-CoV-2 & Flu A/B' has completed European CE-IVD certification and is undergoing document review for emergency use approval by the US Food and Drug Administration (FDA).

This product is a real-time polymerase chain reaction method for the 'SARS-CoV-2' virus gene for the diagnosis of COVID-19 and the 'influenza A' and 'influenza B' virus genes that cause flu from samples taken from human nasal and oral cavity. It is a molecular diagnostic product that can be confirmed by (Real-time PCR).

The government recently introduced a molecular diagnostic test that allows simultaneous testing of COVID-19 flu until November, and applied health insurance, and is concerned about congestion in the medical system due to discrimination between COVID-19 and flu, which have similar symptoms. 'Preparation plan for the simultaneous influenza pandemic' has been announced.

COVID-19 and flu, a respiratory infectious disease, are both difficult to distinguish due to similar symptoms such as high fever, cough, and sore throat. If a flu patient is mistaken for COVID-19 or a COVID-19 patient is mistaken for a flu patient, it is feared that the mortality rate will increase sharply along with the large-scale spread of infectious diseases. In preparation for this, companies around the world are developing various products for accurate identification and diagnosis of COVID-19 and the flu.

On the 8th, SeaSun Biomaterials received approval from the Ministry of Food and Drug Safety for the 'U-TOP COVID-19 Detection Kit Plus' product that enables precise diagnosis of COVID-19.

Unlike competitors that use two genetic judgment indicators so far, this product has upgraded diagnostic reliability with differentiated precision and high accuracy by using four genetic judgment indicators, the largest in Korea.

Seasun Biomaterials previously received high-ranking grades in the sensitivity evaluation for products approved for emergency use of COVID-19 by the US FDA in September, and was recognized for its global molecular diagnostic technology.

SeaSun Biomaterials's COVID-19 molecular diagnostic products and the'One STOP platform', which enables from sample collection to result analysis, are currently being used for COVID-19 diagnosis in countries around the world, including the US, Europe, and Asia.



관련전문:
http://www.healthinnews.co.kr/news/articleView.html?idxno=15365
https://www.etnews.com/20201104000059
https://www.ekn.kr/web/view.php?key=20201104010000905
https://www.fnnews.com/news/202011040956523880
http://www.mdtoday.co.kr/mdtoday/index.html?no=404778