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S.Korean coronavirus test kit makers win U.S. FDA pre-approval

Reuters | Washington DC | Updated: 28-03-2020 17:33 IST | Created: 28-03-2020 16:15 IST
S.Korean coronavirus test kit makers win U.S. FDA pre-approval
Representative Image Image Credit: Twitter(@SAgovnews)

Three Korean coronavirus test-kit makers have won preliminary approval from the U.S. Food and Drug Administration (FDA), paving the way for kits to be exported to the United States to help it battle the largest outbreak of the virus in the world. South Korea's foreign ministry said that winning the preliminary approval under emergency use authorization will allow the products to be sold in the United States.

The ministry did not name the manufacturers or give a time frame in its statement. Earlier this week, U.S. President Donald Trump asked his Korean counterpart to supply the medical devices and promised to help Korean firms gain U.S. regulator approval.

A massive testing campaign, coupled with intensive contact tracing, is credited with helping South Korea slow the spread of the disease, whereas the United States has been criticized for a slow response to the virus. The approval is expected to speed up the ability to test patients in the United States, where critics say the rolling out of tests has been too slow.

Swiss firm Roche won Emergency Use Authorization from the FDA for its test kits earlier this month. The U.S. became the first country to reach 100,000 coronavirus cases this week, with fast-growing outbreaks in a number of states, including New York and New Jersey.

South Korea said on Wednesday it would tighten border controls for travelers from the United States. It warned it would deport foreigners and could jail citizens if they violate self-quarantine rules, after a surge in imported coronavirus cases. South Korea reported 146 new coronavirus cases on Friday, the highest number in a week, its disease control agency said on Saturday.

The Korea Centers for Disease Control and Prevention (KCDC) said 41 of the 146 were imported cases, including 25 from Europe and 11 from the United States. The daily tally brought the country's total infections to 9,478 according to the KCDC. The death toll rose by five to 144.

The country has reported similar daily numbers for the past two weeks, down from a high of over 900 in late February.



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