Rapid, Portable, Point-of-Care COVID-19 Test Receives USD 13 Million Funding from BARDA

Cue Health Inc. (San Diego, CA, USA), a healthcare technology company, has been awarded a USD 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 Cue Health Monitoring System enables a range of in-home and in-clinic diagnostics. The system uses a highly portable reader system to test clinical samples in a disposable test cartridge and sends the results to a connected mobile application. The Cue Influenza test cartridge, which is undergoing clinical validation is designed to detect Influenza A and B. The funding, which was awarded by BARDA, part of the Assistant Secretary for Preparedness and Response (ASPR) at the US Department of Health and Human Services, will enable Cue to accelerate the development and validation of its molecular COVID-19 test. This will pave 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. The company believes that the 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.

“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.”

“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,” added Khattak.

“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.”

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