Cue Health Launches 'Cue for Schools,' an On-Site Molecular Testing Solution for K-12 and Universities

Cue's COVID-19 Test for Home and Over The Counter (OTC) Use - the First-Ever FDA EUA for an OTC Molecular Diagnostic - Provides Lab-Quality Results Directly to Connected Mobile Smart Devices in About 20 Minutes

Cue's COVID-19 Test is Already in Use in Schools Across the United States

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Cue Health Inc.

Apr 05, 2021, 12:01 ET

SAN DIEGO, April 5, 2021 /PRNewswire/ -- Cue Health Inc. ("Cue"), a healthcare technology company, today announced "Cue for Schools," a COVID-19 on-site testing solution for K-12 schools and universities that uses the Cue Health Monitoring System and the Cue COVID-19 Test for Home and Over The Counter (OTC) Use, the nation's first molecular diagnostic test available without a prescription with Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA). Cue's easy-to-use, portable COVID-19 test provides lab-quality results directly to connected mobile smart devices in about 20 minutes and Cue's natively digital platform allows for end-to-end integrated reporting to meet both state and federal reporting standards. Cue's OTC COVID-19 test can be administered by anyone, anywhere making it easy for schools to utilize. As part of the "Cue for Schools" program, schools will receive customized on-site or virtual support for their testing setup on the Cue Health platform, as well as assistance with automatic data reporting which is often the biggest hurdle for schools and school districts looking to implement large scale COVID-19 testing.

Cue's point-of-care COVID-19 test is already being used in K-12 schools as part of the $481 million award from the Department of Defense and the U.S. Department of Health and Human Services. Cue is being used by schools in Philadelphia, the sixth largest school district in the country, as well as schools in Seattle, and Fairbanks, AK, among others. Cue has also loaned hundreds of mobile smart devices to schools to support their testing programs.

"Testing has a critically important role to play in returning to in-person learning. Cue's molecular test offers the accuracy of a lab quality test and it can be done on-site in 20 minutes so schools can reopen safely and confidently," said Ayub Khattak, co-founder and CEO of Cue. "Cue is already being successfully used by schools across the country to create a safer and healthier environment, and now with 'Cue for Schools,' we're expanding our easy-to-use, accurate, and fast testing solution to help bring more students and teachers back into the classroom."

In addition to schools, Cue's COVID-19 tests are also being used in a range of clinical and point-of-care settings, including essential businesses, nursing homes and other congregate care facilities, hospitals, physicians' offices, dental clinics, and more.

To learn more about "Cue for Schools" please contact [email protected].

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 and at home without a prescription 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 Cue Test Cartridge is a single-use, self-contained, high-sensitivity molecular assay. The Cue Sample Wand is a lower 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 interface for test information, instructions, and display of the test results.

About Cue

Cue is a health technology company focused on empowering people to live their best and healthiest lives by making their health data accessible and actionable. The Cue Monitoring System is a real-time, lab quality, connected, and end-to-end diagnostic solution that fits in the palm of your hand. Cue's first product, the Cue COVID-19 Test is the first molecular diagnostic test to receive authorization from the FDA for at home and over the counter use without a prescription. For more information, please visit www.cuehealth.com.

These products have not been FDA cleared or approved; but have been authorized by FDA under an EUA. These products have been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The emergency use of these products 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 Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.

SOURCE Cue Health Inc.