Cue Health Inc. will receive an $481 Million contract from the Department of Defense (DOD), on behalf of the U.S. Department of Health and Human Services (HHS), to expand Cue’s U.S.-based production capacity and deploy six million molecular, point-of-care Cue COVID-19 Tests by March 2021, as announced on Oct. 13.
This effort, intended to help Cue onshore its supply chain and rapidly increase its production capacity, is being led by the DOD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND), in coordination with the DOD Joint Acquisition Task Force (JATF), and is funded through the HHS Office of the Assistant Secretary for Health to enable and support domestic production of critical medical resources. Manufacturing of the Cue COVID-19 Test Cartridges will be performed exclusively at Cue’s facilities in San Diego, California.
The deployment of substantial quantities of Cue’s point-of-care COVID-19 Test will not only increase national COVID-19 testing capacity but will also significantly reduce the time to obtain molecular test results for individual patients to about 20 minutes.
In June 2020, the Cue Health Monitoring System and Cue COVID-19 Test received Emergency Use Authorization from the U.S. Food and Drug Administration. The authorization allows the Cue COVID-19 Test to be used by anywhere at the point-of-care, in conjunction with authorized laboratories, as directed by healthcare providers. Cue’s COVID-19 Tests are currently being used at point-of-care in traditional healthcare, educational, and enterprise settings throughout the country, as part of larger health and safety protocols, to quickly test and resume operations.
Cue has spent more than 10 years developing its highly portable, compact, connected testing platform and is pursuing regulatory approvals for home use. The company has partnered with the Biomedical Advance Research Development Authority (BARDA), a division of HHS, since 2018 to develop other Cue products including a molecular Influenza test, with the option to expand the effort to include coronaviruses. BARDA announced its collaboration with Cue to accelerate the development, validation, and manufacturing of Cue’s COVID-19 test on March 31, 2020.