FDA Did Not Authorize 2-Minute Test

FDA Did Not Authorize 2-Minute Test

CHICAGO (AP) -- A California company falsely claimed cargo planes were ready to ship millions of blood tests that could detect the new coronavirus in just two minutes and had won emergency authorization from the federal government.

The Food and Drug Administration confirmed Wednesday, however, that it has not authorized any such test to be used for diagnosing coronavirus. The federal agency has warned of people peddling fraudulent coronavirus tests, vaccines, drugs and medical devices.

Media outlets around the world picked up the false news after an entity calling itself Bodysphere Inc. distributed a press release claiming it got such approval.

California state business filings do not show any record of Bodysphere Inc. A phone number listed on Bodysphere's website was disconnected and later removed from the site by Wednesday afternoon. A publicist for Bodysphere did not return repeated requests for comment.

In its press release Tuesday, Bodysphere claimed its test had already been "used successfully in several states." It was published a day after President Donald Trump touted the FDA's approval last week of a swab test that can detect the illness in five minutes.

"GOOD NEWS," one Twitter user wrote to his 16,000 followers, sharing an article about the supposed authorization. A senator and Trump's campaign manager also shared the news.

The press release was published to Business Wire, a company that disseminates releases to media outlets, bloggers and websites around the world, including APNews.com.

The release was removed from Business Wire's platform Wednesday after The Associated Press questioned it. It was subsequently scrubbed from the AP's website. It was never used by the AP in its news report.

Business Wire said it promptly removed Bodysphere's press release after being alerted to concerns about it.

"We are continually evaluating our distribution criteria to ensure we are making appropriate enhancements and protecting against similar issues going forward," a spokesman for Business Wire said in a statement.

Bodysphere's website lists a variety of coronavirus-related products, including hospital beds and masks. The online catalog displays pictures of the products with an FDA logo next to them. The items are not available for direct purchase, but the company claims it can produce as many as 1.5 million test kits per week.

Several phone numbers listed for the company's CEO, Charlton Lui, were disconnected. A man listed as Bodysphere's chief pharmacist declined to speak when the AP contacted him by phone at his Las Vegas compounding pharmacy.

Companies around the world are working on blood tests similar to the one Bodysphere touted. They can show who has been infected in the recent past, but not necessarily who is currently sick.

In the U.S., more than 15 companies have notified the FDA that they have developed the tests, the agency said last week. Companies are permitted to begin distributing the tests to hospitals and doctors' offices, provided they carry disclaimers that the tests haven't been reviewed by the agency.

The tests can help researchers understand how widely an infection has spread in a community.

However, they are not reliable for detecting coronavirus as it actively spreads, said Northwestern University's Institute for Global Health director Robert L. Murphy.

"I would be very wary of anybody trying to sell an antibody tests," Murphy said.

In an email, the FDA said it is not authorizing any blood tests for detection of coronavirus.