Rapid response to CBRN, pandemic influenza and emerging infectious disease threats requires a robust investment in diagnostics and devices across the spectrum of advanced research & development, stockpiling and domestic manufacturing capacity expansion.
EUAs/INDs for BARDA-supported Products
DDDI MCM Products in Portfolio
BARDA’s Detection, Diagnostics, and Devices Infrastructure Division funds the development of testing and medical device countermeasures, along with select cases for domestic manufacturing capacity, to produce them to address all threats in BARDA’s mission space: CBRN, influenza, and emerging diseases.
These investments are for development of testing systems and medical devices for use across the entire spectrum of use cases, from traditional hospital or central laboratory settings to limited healthcare resource settings, such as outpatient clinics, doctor’s offices, nursing homes, tribal clinics, businesses, temporary healthcare facilities and even homes. DDDI invests in products through-out the product development life cycle, from late-stage research through FDA clearance/Licensure.The majority of DDDI’s investments are for development of medical countermeasures to diagnose & detect specific infectious diseases such as biothreats, Influenza, or emerging diseases. Others are for improving the quality of casualty care, such as informing the appropriate and effective prescription of antibiotics, estimating the amount of ionizing radiation a casualty has absorbed, or medical devices to alert the potential of an adverse health condition, simplifying collection or processing of patient testing samples, novel respiratory protection devices.
Area of Interest (AOI) 7.7.5 Screening Tests at Point of Care (2-minute Time to Result)
Under BARDA’s Broad Agency Announcement, we are seeking proposals for the development, FDA Emergency Use Authorization (EUA) and FDA 510k clearance of a low-cost, portable, easy-to-use, Point of Care, In-Vitro diagnostic test to detect COVID-19 disease. Tests should analyze specimens that can be easily collected in CLIA-waived settings and provide results in 2 minutes or less.
BARDA scientists started working with private-sector partners in January 2020, days after the novel coronavirus was first reported. BARDA continues to support test development and has expanded support of programs that increase testing speed and capacity for lab tests, as well as broaden access to testing by developing point-of-care and home-use platforms.