Cue Health Awarded $13 Million for Rapid, Portable, Point-of-Care COVID-19 Test by U.S. Department of Health and Human Services Biomedical Advanced Research and Development Authority (“BARDA”)
San Diego, CA (March 31, 2020) - Cue Health Inc. (“Cue”), a healthcare technology company, announced that is has been awarded a $13 million contract to accelerate the development, validation and FDA clearance of a portable, molecular diagnostic test capable of detecting SARS-CoV-2, the virus that causes COVID-19, in less than 25 minutes using a simple nasal swab. The test is part of the Cue Health Monitoring System, which is designed to be a portable device that can perform a molecular test and connect patients to a mobile health platform that features interventional components such as telemedicine consultations.
The funding was awarded by BARDA, part of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services. The funding will enable Cue to accelerate the development and validation of its molecular COVID-19 test, paving the way for its scale-up to facilitate on-the-ground management of this pandemic cycle and prepare for similar infectious disease outbreaks in the future.
“We aim to help provide a diagnostic shield for people at home, their business, and the healthcare system that will allow us to gain the upper hand against viral threats now and in the future.” said Ayub Khattak, CEO of Cue Health. “We have worked with the BARDA team for the past two years developing and testing a 20-minute, molecular influenza test designed for home and point-of-care use. Our connected platform could serve as a critical tool in identifying the SARS-CoV-2 virus. Rather than waiting days for results or sending samples off to a lab, having test results in 25 minutes could drastically improve our ability to contain the spread of the virus for this and future pandemics.”
“We are committed to making rapid point-of-care tests to detect SARS-CoV-2 available as quickly as possible,” said BARDA Director Rick Bright, Ph.D. “Tests that can be used reliability in alternate care sites will provide faster results to more people. Public-private partnerships are essential in providing solutions to curb the spread of COVID-19 now and also to mitigate future coronavirus outbreaks.”
Khattak concluded that distribution of the Cue platform could have significant impacts on the management of the current public health crisis – allowing regular screening by professionals and eventually testing to be performed at home or in the community. “Our ultimate goal is to change the way professionals and consumers access important health information. We plan to equip thousands of clinics, schools, eldercare facilities and homes with affordable, rapid and accurate testing capabilities. That infrastructure would enable on-demand diagnostic testing for families, and in the case of a viral or other biothreat, the ability to monitor a global, connected network producing real-time epidemiological data.”
*This project has been funded in whole or in part with Federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority, under Contract No. HHSO100201800016C
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
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.
March 31, 2020
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