SAN DIEGO, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Cue Health Inc. (Cue) announced today that, as of November 9, the U.S. Department of Health and Human Services (HHS) began deploying its molecular, point-of-care COVID-19 Tests to five states, including Alaska, Florida, Louisiana, New Jersey, and Texas. The tests will be utilized for quick confirmatory testing of positives and suspicious negatives in high-concern populations and congregate care settings, such as nursing homes, long-term care, assisted living facilities, and veterans’ homes. The tests will also be used internally at the Department of Defense (DOD).
“Our mission as a company has always been to provide patients and healthcare providers with access to actionable, accurate health data in real-time,” said Ayub Khattak, Founder & CEO of Cue. “The deployment of Cue’s point-of-care COVID-19 Test will not only increase molecular testing capacity in critical locations but will also help protect the health of the most vulnerable populations by providing real-time results in about 20 minutes.”
“The Cue Health testing system will undoubtedly be a valuable addition to our testing ecosystem,” noted HHS Assistant Secretary for Health ADM Brett Giroir, M.D. “Having a highly specific and sensitive POC molecular test could dramatically improve infection control at nursing homes and other institutional settings.”
The Cue Health Monitoring Systems and the Cue COVID-19 Tests will be delivered to a single designated location. The governors’ offices, working closely with their state health departments, will determine allocations and further deployment to local and regional facilities based on their respective and evolving needs. Based upon the concept of use and the different situations for access to care, the distribution will be adjusted. For example, Alaska will receive 200 Monitoring Systems and 9,000 test cartridges due to the remote nature of access to testing. Meanwhile, Florida, Louisiana, New Jersey, and Texas will each receive 100 Monitoring Systems and 4,500 test cartridges. This deployment of tests to the pilot participants is the initial deployment, with tens of thousands more tests to be manufactured and deployed in the next weeks. In each of the states, Cue plans to provide immediate onboarding and training support for facilities that receive its test.
Cue’s COVID-19 Test is a portable, compact, easy-to-use, molecular test that detects the RNA of SARS-CoV-2 using a nasal swab (the Cue Sample Wand) taken from the lower part of the nose by a trained healthcare provider. Specimen collection and execution of the test is simple, requires minimal training, and is completely automated in its process of sample to result. Cue’s molecular assay and connected platform, which provide results to a mobile smart device in about 20 minutes, is an efficient solution for frequent, fast, reliable testing at point-of-care.
The Cue COVID-19 Test received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) on June 10, 2020. The test is performed by a healthcare professional under the supervision of an Authorized Laboratory operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
On October 13, 2020, the HHS and DOD announced an award to Cue that will enable the company to expand its industrial base and U.S. production capacity to deliver six million COVID-19 tests and 30,000 Monitoring Systems to the U.S. Government by March 2021, to support the domestic pandemic response. This effort 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 funded through the HHS Office of the Assistant Secretary for Health, to enable and support domestic production of critical medical resources.
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.
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