At-home influenza tests take leap forward

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, California, and Diassess, Inc., of Emeryville, California, to develop these first-in-class 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 BARDA Director Rick Bright, Ph.D. “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 $10M to Diassess for advanced development of diagnostic tests for influenza A and B viruses that are being developed for purchase over-the-counter or administration by professionals. The agreement with Cue Health can be extended for up to a total of $30M over 60 months, the agreement with Diassess can be extended for up to a total of $21.9M over 60 months.

Both companies are designing their devices and tests to be inexpensive, simple for consumers to use, and able to give 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. Such data 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.

BARDA continually seeks innovative products in advanced stages of development for use in combating pandemic influenza and emerging infectious diseases. Apply through the BARDA Broad Agency Announcement (BAA).

About HHS, ASPR and BARDA

HHS works to enhance and protect the health and well-being of all Americans, providing for effective health and human services and fostering advances in medicine, public health, and social services. The mission of the Office of the Assistant Secretary for Preparedness and Response (ASPR) is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the advanced research and development, acquisition, and manufacturing of medical countermeasures – vaccines, drugs, therapeutics, diagnostic tools, and non-pharmaceutical products needed to combat health security threats.

For more about ASPR and BARDA, visit www.phe.gov/aspr. To learn more about partnering with BARDA on advanced development of medical countermeasures – drugs, vaccines and devices for emergencies – visit http://www.medicalcountermeasures.gov.

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