Did the US rush? Roche says "FDA grants emergency approval for COVID-19 diagnostic device 10 times faster"

[Asia Economy Reporter Bu Aeri] Swiss multinational pharmaceutical company Roche Holdings has developed a novel coronavirus disease (COVID-19) testing device that is 10 times faster in diagnostic speed and has received approval from U.S. authorities. Attention is focused on whether the speed of COVID-19 testing in the United States will increase.

According to Bloomberg on the 13th (local time), Roche recently obtained emergency authorization from the U.S. Food and Drug Administration (FDA) for its diagnostic device, the 'Cobas 6800/8800 system.' This system can be used not only in Europe but also in countries that have adopted the CE mark, a safety certification for medical devices. The system analyzes nucleic acids extracted from a patient's saliva or mucus and compares them with sequences found in coronavirus strains.

Roche's Cobas 6800/8800 can provide results within 4 hours, with the 8800 system capable of diagnosing 4,128 patients per day. The 6800 system can determine the COVID-19 infection status of up to 1,440 individuals. Accordingly, it is expected that the diagnostic target can be expanded to millions of people per month.

Until now, the U.S. and Europe have faced criticism that COVID-19 testing was slow, increasing the possibility of further spread.

Thomas Schinecker, head of Roche's diagnostics division, said, "We have significantly increased testing capacity across the United States," adding, "It will play an important role in diagnosing COVID-19 infection status."

This content was produced with the assistance of AI translation services.