The Biomedical Advanced Research and Development Authority (BARDA) and Cue Health will collaborate under a new contract announced today to accelerate the development, validation, and manufacturing of a portable, molecular diagnostic test capable of detecting SARS-CoV-2, less than 25 minutes using a simple nasal swab.
In this public-private partnership, BARDA, part of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services, will provide approximately $13.6 million and expertise for development, validation and manufacturing of the test.
The test is part of the Cue Health Monitoring System, a portable device that not only can perform a molecular test but also can connect patients to telemedicine consultations through the system’s mobile health platform. The test on the Cue platform could potentially have significant impact on the management of the current pandemic by augmenting routine screening and testing to be conducted at point-of-care, including alternate care sites.
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.
Having a test result in under 25 minutes could considerably improve the ability to manage care during a pandemic by helping to triage patients in a more efficient and effective manner.
“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.”
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.”
