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Update: Bodysphere issued a statement clarifying that, in the rush to get its kits on the front lines, it misinterpreted the test’s listing on the FDA registry website. The test has not yet been cleared by the FDA.

Bodysphere announced today that it has begun distributing its 2-minute testing kit for diagnosing COVID-19 after receiving FDA emergency use authorization (EUA).

The Los Angeles-based company’s two-minute testing kit uses antibodies in blood to test for current or past infection with a 91% clinical specificity rate and a 99% clinical sensitivity rate, according to a news release. The test delivers results on-site in as fast as two minutes.

Separately, Becton Dickinson announced a plan to launch a new point-of-care test that can detect antibodies in blood to confirm current or past exposure to COVID-19 in as little as 15 minutes. BD’s test is not meant to diagnose COVID-19.

Bodysphere’s test is a lateral flow chromatographic immunoassay to detect antibodies (IgG and IgM) for the coronavirus in human whole blood/serum/plasma. It is only for administration by medical professionals.

The company said its test kits have already been successfully used in multiple states where large rollouts are in the works for combating the spread of the virus. Bodysphere added that it is working with federal agencies and states to quickly deploy test kits where they are needed.

Bodysphere said it has contracted cargo planes to deliver the product to the front lines and touted its capability of having millions of test kits reach those front lines within weeks.

“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,” Bodysphere CEO Charlton Lui said in the news release. “Thankfully when our perpetual quest for improving health put us in a position to deliver this lifesaving product – it became quite clear what we had to do.”

Filed Under: Business/Financial News, Diagnostics, Featured, Food & Drug Administration (FDA), Genomics/Molecular Diagnostics, Regulatory/Compliance Tagged With: Bodysphere, coronavirus, COVID-19, FDA

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