Cue Announces $30 Million Funding Contract from U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority
San Diego, CA (July 12, 2018) - Cue Health Inc. (“Cue”), a healthcare technology company, announced today that is has been awarded up to $30 million in base funding and options from the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (“BARDA”) to accelerate the development and regulatory validation of an over-the-counter and professional use Influenza and Multiplex Respiratory Pathogen diagnostic cartridges for the Cue Health Monitoring System.
“BARDA’s expertise in the development of advanced medical technologies will be a great asset to Cue as we spearhead a new approach to dealing with the persistent threats of influenza and other respiratory pathogens,” says Ayub Khattak, CEO of Cue Health.
The Cue Health Monitoring System centers around a connected diagnostic device, which enables a range of in-home and in-clinic diagnostics. The system uses a custom designed reader to test clinical samples in a disposable test cartridge and then sends the results to a mobile application. The mobile application provides access to features including interventional components such as telemedicine consultations for consumers and prescribing capabilities for physicians. The Cue Influenza Cartridge will be focused on detecting Influenza A and B. The Cue Multiplex Respiratory Pathogen Cartridge will be a multiplex assay capable of detecting and differentiating between multiple respiratory pathogens.
*This project has been funded in whole 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. BAA-16-100-SOL-00002
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.
July 12, 2018
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