Back to Newsroom

Cue Receives $481 Million Award by DOD and HHS to Expand Domestic Production Capacity and Provide 6 Million Molecular, Point-of-Care COVID-19 Tests

October 13, 2020

  • Cue’s COVID-19 Test is an accurate, point-of-care molecular test that detects the RNA of SARS-CoV-2 using a nasal swab sample taken from the lower part of the nose.
  • Test results are delivered in about 20 minutes from the easy-to-use, automated, reusable Cue Cartridge Reader to the Cue Health App.
  • Cue’s COVID-19 Test runs on the portable and compact Cue Health Monitoring System, which consists of a Cue Cartridge Reader and single-use test kits. Each single-use COVID-19 Test kit includes a Cue Sample Wand and COVID-19 Test Cartridge.

San Diego, CA (October 13, 2020) - Cue Health Inc. (Cue) announced today 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. 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.

“We are excited to be part of this historic, first-of-its-kind initiative led by the U.S. Government to deploy point-of-care molecular testing to protect the health of Americans,” said Ayub Khattak, Founder & CEO of Cue. “Our vision in designing the Cue Health Monitoring System was to enable individuals to have more control over their health and lives by providing access to actionable, accurate health data in real time. The U.S. Government’s support has and will allow us to fulfill this vision in this particularly critical moment.”

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. 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.

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.

This test has not been FDA cleared or approved; this test has been authorized by FDA under an EUA for use by authorized laboratories; this test has been authorized only for the detection of nucleic acid from SARSCoV-2, not for any other viruses or pathogens; and this test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

Media Inquiries

Follow Us

Stay up to date on the latest from Cue