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
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
“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