SAN DIEGO, Oct. 13, 2020 /PRNewswire/ -- 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.
About the Cue Health Monitoring System
The Cue Health Monitoring System is a portable, compact, connected diagnostic platform that provides the power of lab-quality molecular testing at point-of-care, when and where it is needed the most. The Cue Health Monitoring system works with the Cue Test Cartridge, the Cue Sample Wand, and the Cue Health App to convert test samples into accurate digital results. The single-use Cue Test Cartridge contains all the biochemistry needed to perform the molecular test. The Cue Sample Wand is a nasal swab supplied with the Cue Test Cartridge. The reusable, battery-operated Cue Cartridge Reader runs the Cue Test Cartridge and communicates results directly to the Cue Health App in about 20 minutes via a mobile smart device. The Cue Health App on the user's mobile smart device is the user interface for test information, instructions, and display of the test results. Designed as a complete diagnostic tool, the Cue Health Monitoring System along with the Cue Test Cartridge and the Cue Health App deliver actionable health data at point-of-care.
COVID-19 Test Cartridge
The Cue COVID-19 Test Cartridge is a single-use, self-contained unit that utilizes proprietary technology to apply the reagents and associated materials required for molecular detection of the SARS-CoV-2 virus, the virus that causes COVID-19. The Cue COVID-19 Test is a high-sensitivity molecular assay that is being deployed to address urgent unmet needs in COVID-19 testing. On June 10, 2020, Cue received Emergency Use Authorization (EUA) from the US Food and Drug Administration for use of the Cue COVID-19 Test Cartridge with the Cue Health Monitoring System to detect nucleic acid from SARS-CoV-2 in nasal specimens from individuals who are suspected of COVID-19 by their healthcare provider.
About Cue Health
Cue Health Inc. ("Cue") is an ISO 13485-certified company founded by Ayub Khattak and Clint Sever focused on developing and manufacturing professional and consumer medical diagnostic products that can be used in clinical or at-home settings. Cue's mission is to create tools that empower healthcare providers and consumers by increasing their access to actionable health data. Cue's first product, the Cue Health Monitoring System with the Cue COVID-19 Test Cartridge, is a platform that provides diagnostic information to clinicians and patients seeking to benefit from a connected healthcare delivery ecosystem. The company is based in San Diego, CA. For more information visit www.cuehealth.com
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.
SOURCE Cue Health Inc.