Cue Health Inc., a healthcare technology company, announced that it has received EUA from the U.S. FDA for the company’s rapid, portable, point-of-care COVID-19 test. The Cue COVID-19 Test is a molecular test that detects the RNA of SARS-CoV-2, the virus that causes COVID-19, in 25 minutes using a nasal swab sample taken from the lower part of the nose.
Cue’s COVID-19 test runs on the compact and portable Cue Health Monitoring System. A single-use COVID-19 test kit includes a Sample Wand and COVID-19 Test Cartridge. The system performs rapid molecular analysis at the point-of-care and transmits test results to the Cue Health App on a connected mobile device. The current FDA EUA allows the Cue COVID-19 test to be used anywhere under the supervision of qualified medical personnel. The company is intending to seek additional FDA authorizations for use of the COVID-19 test in settings such as the workplace, schools, and at home.
“We are very pleased to have received FDA EUA for our Cue Health COVID-19 Test. We believe our product can help provide greater access to rapid, distributed COVID-19 testing necessary for clinical decision making and to get our country back to work,” said Ayub Khattak, CEO of Cue.
Development and validation of the Cue Health COVID-19 test was supported by funding awarded by the Biomedical Advanced Research and Development Authority (“BARDA”), part of the Office of the Assistant Secretary for Preparedness and Response (“ASPR”) at the U.S. Department of Health and Human Services. BARDA announced its collaboration with Cue to accelerate the development, validation and manufacturing of Cue’s COVID-19 test on March 31, 2020.
Cue plans to initially launch its COVID-19 test with select leading healthcare institutions and their satellite centers, followed by nationwide deployment across a variety of healthcare settings.
In addition to its COVID-19 test, Cue is developing additional test cartridges for use with the Cue Health Monitoring System, including tests for Influenza A/B. Cue envisions that in the coming years it will be able to leverage its advanced diagnostic testing platform to enable testing for a variety of infectious diseases in settings such as homes, schools, and businesses, in addition to clinical settings.
About Emergency Use Authorization Status
The Cue COVID-19 Test has not been FDA cleared or approved. The test has been authorized by the FDA under an EUA for use by clinics and laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (“CLIA”), 42 U.S.C. § 263a, to perform diagnostic tests. The test has been authorized only for the detection of RNA from SARS-CoV-2 virus and diagnosis of SARS-CoV-2 virus (COVID-19) infection, not for any other viruses or pathogens. The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostics for detection of SARS-CoV-2 virus under section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is extended, terminated or revoked sooner.
About Cue Health
Cue Health Inc. 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 physicians 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 rapid diagnostic information to clinicians and patients seeking to benefit from a connected healthcare delivery ecosystem. The company is based in San Diego, CA.