FDA's lax blood test rules open US market to dubious vendors: Report

The rush to obtain test kits follows the FDA's unprecedented decision last month to allow any company to sell antibody tests in the US without prior review by the agency

As the coronavirus pandemic engulfed the United States, Joe Shia, a consultant to Chinese medical companies, said he was bombarded with inquiries from American firms who saw a golden opportunity in selling tests to determine coronavirus immunity.

Unlike his typical clients, some firms seeking his help had never before sold medical equipment. Others wanted to register test kits with the US Food and Drug Administration without approval from the manufacturer, or to offer home-based tests, which are not allowed by the FDA. One was in the window business, he said.

"They replace windows and do window cleaning," said Shia, adding that he