WASHINGTON – Two potential diagnostic tests for influenza, designed to be purchased over-the-counter for home use, will move into advanced development with new support from the U.S. Department of Health and Human Services.
The Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), is partnering with Cue Health, Inc., of San Diego, and Diassess, Inc., of Emeryville, Calif., to develop the testing devices.
“Empowering people to answer the basic question, ‘Do I have the flu?’ without leaving home could have a profound effect on controlling and treating influenza, whether it’s seasonal or a wide-spread pandemic,” said Rick Bright, director of BARDA, in a statement. “Putting that power in patients’ hands could transform the speed and delivery of care. In a pandemic, that equates to lives saved and stronger national health security.” BARDA will provide $14 million to Cue Health and $10 million to Diassess for advanced development of diagnostic tests for influenza A and B viruses that are being developed for purchase over-the-counter for administration by professionals. The agreement with Cue Health can be extended for up to a total of $30 million over 60 months, and the agreement with Diassess for up to a total of $21.9 million over 60 months, said Bright.
Both companies are designing their devices and tests to be inexpensive, simple for consumers to use and able to provide results within 25 minutes. Both devices leverage mobile technology so that patients who test positive for influenza can receive a telemedicine consultation and, if needed, a prescription for antiviral drugs without leaving home.
The devices also may include the capability to report de-identified influenza data to local health departments in real-time, which would give public health authorities earlier warnings of possible outbreaks or pandemics, while safeguarding patient privacy.
The Diassess testing device would be disposable and battery-powered for use in the field, where resources may be limited during public health emergencies. Cue Health also is developing its device to test for other viruses, including Zika and HIV.