Cue Health Inc. has announced a $481 million award 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. 

The Cue COVID-19 Test is an isothermal nucleic acid amplification assay intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in direct nasal swabs or previously collected nasal specimens in viral transport media from individuals who are suspected of COVID-19 by their healthcare provider.

The test is run using the Cue Health Monitoring System (Cue Cartridge Reader), the Cue COVID-19 Test Cartridge, the Cue Sample Wand, and the Cue Health App on the Apple® iPhone® 8+ or newer mobile smart device with iOS 13 (or higher).

The test, according to Cue, has 99% sensitivity and 98% specificity and a limit of detection of 20 genome copies per sample. 

This contract is 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 EUA 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.  

Mayo Clinic conducted a prospective study to evaluate the accuracy of the Cue COVID-19 Test. Preliminary information was made available to the HHS. Mayo Clinic and its collaborators plan to publish the full results in the future.

The company has partnered with the Biomedical Advanced 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.