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

FILE PHOTO: Women wearing masks to protect against contracting the coronavirus disease (COVID-19) walk along a street in Seoul, South Korea
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By Cynthia Kim

SEOUL (Reuters) - 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.

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.

U.S. President Donald Trump this week 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 has also won Emergency Use Authorization from the FDA for its test kits.

The United States 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 foreign citizens and could jail people if they violate self-quarantine rules, after a surge in imported coronavirus cases.

South Korea reported 146 new coronavirus cases on Friday, 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.

That brought South Korea's total infections to 9,478, according to the KCDC, with a death toll of 151, up from 139.

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

(Reporting by Cynthia Kim; editing by Ros Russell and Jason Neely)