Korean Covid test exporters fret business in limbo as life returns normalcy

2022.04.26 14:58:16 | 2022.04.26 15:03:07

[Photo by Yonhap]이미지 확대

[Photo by Yonhap]

Korean Covid-19 test kit makers are fretting over their hastily-expanded business as they may lose emergency use authorizations (EUAs) amid return to normalcy in the U.S. and other parts of the world.

If they lose EUA, they no longer can sell the kits that have not been formally approved by the Food and Drug Administration (FDA).

Sales will likely stay unaffected until June, but dip is inevitable in the second half, said an official from a Korean diagnostic kit developer on Monday.

The removal of EUA could devastate shipments.

The FDA is expected to recommend test makers to seek an official route for distribution of their products for the upcoming endemic era. The FDA already issued a guidance for distributors of Covid tests authorized for emergency use on how to respond to the post-pandemic world.

Test products being distributed under the EUA in the U.S. are 271 molecular diagnostic tests, 50 antigen tests, 84 blood serum tests, and four for patient management purposes. When the U.S. Department of Health and Human Services determines the end of EUAs, the companies of these tests must either remove their products from the U.S. market or get them approved under the standard process.

There may be a transition of 180 days until the actual end of EUAs, but the time for market re-entry is quite short considering the disposition of existing tests, labeling change, and filing for formal approval, according to an official from another Korean company.

Such concerns come after exports of Korean Covid tests are on a downward trend with the pandemic showing signs of weakening around the world. Exports of such products came to $81.28 million in April 2021 but the corresponding figure for this month is estimated to be at $7.5 million. SD Biosensor, the largest Korean Covid test exporter, may see a considerable decline in revenue this year from its peak in last year.

By Kim Si-gyun and Minu Kim

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