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BodySphere’s 2-minute coronavirus test gets FDA emergency clearance

BodySphere said its tests have a 91 percent clinical specificity rate and a 99 percent clinical sensitivity rate.

BODYSPHERE

I-Chun Chen, ReporterMar 31, 2020, 2:02pm PDT

Los Angeles-based BodySphere Inc. said it has been cleared to distribute its new two-minute COVID-19 testing kit and has contracted cargo planes to deliver the product to the front lines of health care facilities. 

The U.S. Food and Drug Administration has issued Emergency Use Authorization for the company’s test which uses antibodies in blood to test for current or past infection. 

BodySphere said its tests have a 91 percent clinical specificity rate and a 99 percent clinical sensitivity rate.

Results are delivered on site in as fast as two minutes, rather than current COVID-19 tests, which take two to seven days for results. In addition, the test can be administered as easily as a glucose test but is designed strictly for use by medical professionals, the company said.

BodySphere is led by Chief Executive Charlton Lui, a tech veteran who worked with Bill Gates to develop the tablet PC. Lui also has worked at Apple (Nasdaq: AAPL) and Stanford Research Institute, and co-founded Truetype font and the first multi-media internet conferencing.

“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.” Lui said in a statement. “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.” 

BodySphere said its test kits have been used successfully in several states where large roll outs are planned. It also is working closely with federal agencies and states to quickly deploy test kits across the country to hospitals, urgent care and emergency rooms. The company said it is positioned to have millions of test kits on the front lines in weeks.