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Wednesday, October 21, 2020

HHS invests $480 million in Cue Health to boost manufacturing of rapid coronavirus test

The U.S. is investing $481 million in California-based start-up Cue Health to boost manufacturing of its coronavirus test that produces results in about 20 minutes and without needing to be processed at a lab, U.S. agencies announced Tuesday.

Cue, which is backed by Johnson and Johnson among other investors, will increase production to 100,000 test kits per day by March, according to the Department of Health and Human Services. It added that the U.S. will acquire 6 million tests and 30,000 lab instruments used to process the tests.

“Cue’s tests provide results in about 20 minutes with the kind of accuracy provided by lab tests that can take several days, adding to our dramatically expanding supply of rapid tests that can support safe reopening,” Alex Azar, Secretary of HHS, said in a statement.

Cue is a molecular test and it uses an in-house nasal swab, called the Cue Sample Wand, collected from the lower part of the nose, HHS said. That’s different from some other rapid molecular tests that use nasopharyngeal swabs inserted deep into the nose.

Test results can be delivered directly through the Cue Health mobile app, HHS said.

“The Cue testing system is highly sensitive and specific, and nearly equivalent to the best large referral laboratory systems,” Adm. Brett Giroir, assistant secretary of health who leads the government’s testing effort, said in a statement. “This investment will allow Cue Health, Inc. to expand its footprint and significantly scale up production, and by doing so enable this technology to be deployed throughout our testing ecosystem to benefit all Americans.”

The company announced on June 12 that it received an emergency use authorization for the test from the Food and Drug Administration. The regulatory agency authorized the test to be used “anywhere under the supervision of qualified medical personnel,” the company said.

The test was developed in partnership with the Biomedical Advanced Research and Development Authority, which is part of HHS. The partnership began in 2018, when BARDA awarded $14 million to Cue develop a molecular influenza test with the option to extend the agreement up to 60 months for a total of $30 million. Early in the pandemic, BARDA expanded its partnership with Cue to develop a test for the coronavirus.

“This award exemplifies the importance of agencies like BARDA,” Giroir said.

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