Test maker disputes claim of would-be U.S. seller of ‘two-minute’ coronavirus diagnostic

(Reuters) – BodySphere, which describes itself as a distributor of medical products needed to combat the coronavirus pandemic, has falsely claimed that it has access to a rapid diagnostic test made by Safecare Biotech in China for sale in the United States, the test manufacturer told Reuters.

BodySphere announced in a press release published on Business Wire on Tuesday that it was authorized by the U.S. Food and Drug Administration to distribute a two-minute diagnostic test for coronavirus that identifies through a small blood sample whether a person has produced antibodies to the coronavirus, an indicator of exposure to the virus.

The BodySphere statement referred to the test kit as a “game changer” for the United States, where it can take several days or more to receive coronavirus test results.

The press release quoted Charlton E. Lui, identified as BodySphere’s chief executive officer, as saying: “When we realized we had the ability to step up and fight this pandemic at a critical point, we focused all our resources on bringing the rapid test kits, masks and other critical supplies to the front lines as soon as possible.”

Reuters published a story based on the press release and made inquiries to BodySphere and FDA about the test. Reuters withdrew the story on Wednesday after D’Anne Mica, a spokeswoman representing BodySphere, said the company had not received the emergency authorization.

“BodySphere mistakenly believed when the manufacturer’s product was listed on the FDA Registry website, that was the Food and Drug Administration’s (FDA) notification the Emergency Use Authorization (EUA) was issued,” CEO Lui was quoted as saying in a statement sent by Mica.

Reuters was unable to reach Lui directly for comment.

Business Wire issued a kill notice to withdraw the BodySphere press release on Wednesday and said it did so after becoming aware of concerns about the statement.

As proof of the test kit’s registration by the FDA, Mica provided Reuters with a link from the agency’s website listing a test produced by Safecare Biotech, a Chinese firm based in the city of Hangzhou.

A Safecare representative in China told Reuters that the company does not have a U.S. distribution contract with BodySphere. Safecare also said that its coronavirus test takes 10 to 15 minutes to deliver results, not two minutes as claimed by BodySphere.

Mica also provided Reuters with a letter from the FDA to Joe Shia, manager of a Maryland-based consultancy called LSI International, acknowledging the submission of information on a rapid test for coronavirus antibodies produced by Safecare.

Safecare confirmed that it is working with LSI to register its product in the United States.

LSI’s Shia said in a telephone interview that he had submitted paperwork on behalf of Safecare to request emergency authorization from the FDA. Shia said that he has had no contact with BodySphere.

Mica did not respond to requests for comment on the statements by Safecare or LSI.

The FDA declined to comment on BodySphere’s claims, saying it cannot speak about any specific company. FDA spokesman Michael Felberbaum said that the agency had not issued emergency-use authorization for any serological test related to the coronavirus as of Wednesday.

Reporting by Roxanne Liu in Beijing, Alex Harney in Hong Kong, Shanghai newsroom; Additional reporting by Caroline Humer in New York; Editing by Michele Gershberg and Will Dunham

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