Trump Administration Makes Major Investment to Increase Availability of Fast Molecular POC Test

Department of Health and Human Services

The U.S. Department of Health and Human Services (HHS) in collaboration with the Department of Defense (DOD) awarded a $481 million Other Transaction Agreement to Cue Health, Inc. to expand U.S. production capacity for a cartridge-based point-of-care COVID-19 molecular test that produces results in about 20 minutes. This partnership with HHS and DOD will allow Cue to expand its industrial base and increase domestic production to 100,000 COVID-19 test kits per day by March 2021, and demonstrate this capacity through the delivery of six million COVID-19 tests and 30,000 instruments to the U.S. Government to support the domestic COVID-19 pandemic response.

“Supporting Cue’s production of millions of new point-of-care tests is the latest achievement of the public-private testing partnership the Trump Administration has built,” said HHS Secretary Alex Azar. “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.”

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The Cue COVID-19 Test is a molecular test that detects the ribonucleic acid (RNA) of SARS-CoV-2, the virus that causes COVID-19 infection, in about 20 minutes using a nasal swab collected from the lower part of the nose using the Cue Sample Wand, which is part of the test kit.

“The Cue testing system is highly sensitive and specific, and nearly equivalent to the best large referral laboratory systems. It is FDA-authorized for use in anyone suspected of having COVID-19 by their health care provider,” said ADM Brett Giroir, M.D. “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 system can be used for analysis of nasal specimens at the point-of-care and transmits test results to the Cue Health App on a connected mobile smart device. The U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) allows the Cue COVID-19 Test to be used in patient care settings under the supervision of qualified medical personnel, operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.

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Development and validation of the Cue Health platform was supported by funding awarded by the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at HHS, starting in 2018 for the development of a molecular influenza test. In response to the pandemic, BARDA expanded its collaboration with Cue to accelerate the development, validation and manufacturing of Cue’s COVID-19 test on March 31, 2020.

“This award exemplifies the importance of agencies like BARDA, which invest in platform technologies that can be applied to diverse health security needs, as well as HHS’s collaboration with the DOD, which brings disciplined processes, unequalled acquisition expertise, and the urgency needed to respond to this pandemic,” said Admiral Giroir.

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