Cue Partners with J&J Innovation to Fight HIV in Developing World
SAN DIEGO, CA--(Marketwired - Feb 4, 2016) - Cue, Inc. today announced a collaboration with Janssen Pharmaceuticals, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, (Janssen) to address a significant global health need for HIV viral load testing using Cue's Lab-In-A-Box proprietary molecular diagnostics platform. The deal was facilitated by Johnson & Johnson Innovation.
Today, access to HIV viral load testing in resource poor settings is limited due to cost, and the technical complexity of the instrumentation and infrastructure required. An affordable, portable, easy-to-use, and internet enabled HIV quantitative viral load test could significantly enhance access to clinically significant information.
Patients with newly emerging viral load who remain on failing regimens run the risk of both disease progression and developing resistance to future treatment options. Hence, HIV viral load testing is key to optimal disease management in people living with HIV.
The scale of the HIV epidemic in Africa, India, Southeast Asia, and other parts of the developing world make this a significant global health challenge to be solved through strategic coordination between diagnostics, therapy, and on-the-ground deployment.
“We're excited to work with Janssen, a leader in the HIV field, to accelerate the development of the HIV quantitative viral load test on Cue's platform. Together we can make a big impact on this significant global health challenge by bringing simplicity, immediacy and affordability to the field of HIV viral load testing in an unprecedented way,“ says Cue CEO Ayub Khattak.
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.
February 4, 2016
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