Did BodySphere jump the gun on '2-minute' COVID-19 test?

2020 01 27 21 38 4451 Lab 2019 Coronavirus Test 400

The news seemed too good to be true: A company called BodySphere claimed to have received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for what it said was a two-minute serological test for detecting COVID-19.

And in the end, it apparently was false. News reports have questioned the company's claims, and BodySphere's chairman and CEO has walked back the company's assertion that it had received the FDA's imprimatur. But the firm said it still intends to sell the test on the market.

BodySphere calls itself a "collection of distinct brands" that focus on delivering wellness and medical products in the U.S., specifically in the pharmaceutical, cosmetics, family, and seniors market segments, according to the company's website. The firm was founded by Charlton Lui, an engineer who did early work at Microsoft on the tablet PC. In addition to the COVID-19 test, the company's website highlights face masks and sanitizing gels.

BodySphere announced the claim on March 31 in a news release, saying the FDA had granted an EUA for its COVID-19 immunoglobulin G/immunoglobulin M (IgG/IgM) rapid test cassette. The company described the test as a lateral-flow chromatographic immunoassay for the detection of IgG and IgM antibodies that would signal infection with SARS-CoV-2 in human whole blood/serum/plasma.

The firm claimed the product was the first serological test for COVID-19, and that it delivered results in two minutes, with 99% sensitivity and 91% specificity. BodySphere said it was preparing to have "millions" of tests available in the U.S.

BodySphere's initial claims were covered widely in the news media, but quickly questions began to emerge. Several news organizations followed up with the FDA itself, which clarified that it had not issued any EUAs for serological COVID-19 tests.

On April 1, a BodySphere spokesperson told CNN that the company's announcement had been the result of a "misunderstanding," and that the FDA had never issued the EUA. This was followed up by an announcement on the company's website by founder and CEO Charlton Lui, who said that BodySphere was the distributor for the test, which was being manufactured by another firm.

"In the rush to get the desperately needed test kits to the front lines, [BodySphere] 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," Lui's statement read. "This misunderstanding does not in any way invalidate the test kit's authenticity or effectiveness. "

Lui further stated that the test's manufacturer has performed clinical trials of the product, and data from those trials will be made available to "to any healthcare provider or government official seeking to validate the effectiveness and authenticity of these tests."

The story illustrates the murky regulatory environment surrounding diagnostic testing for the novel coronavirus. The FDA has come under fire for acting too slowly to approve new tests; in response, the agency on March 16 announced that it would allow tests to be used clinically without first having received an EUA.

At this point, however, BodySphere appears to be waiting for an EUA to be issued -- for certain -- before starting sales of its serological test. Lui said in his statement that the company is "anxiously awaiting" word of the FDA issuing an EUA to the test's manufacturer.

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