BARDA Products Achieve 85th FDA Market Authorization
The latest clearance follows 20 BARDA-supported product approvals or clearances in the last year
Today, the Biomedical Advanced Research and Development Authority (BARDA), an office within the Administration for Strategic Preparedness and Response (ASPR), announced the 85th Food and Drug Administration (FDA) regulatory approval or clearance of products developed with BARDA support. This clearance follows a rapid succession of recent FDA approvals or clearances – more than 20 in the last year.
Each FDA approval or clearance of a medical countermeasure – vaccine, treatment, or device – boosts the United States’ public health preparedness and offers an opportunity to recognize the collaborative work of the scientific community, the federal government, and industry partners.
“BARDA has been at the cutting edge of public health research and development since their inception,” said Assistant Secretary for Preparedness and Response Dawn O’Connell. “The innovative products we have supported are powering our response to COVID-19, mpox, and countless other public health challenges – strengthening our response capabilities and building our preparedness for future threats.”
The first approval of a BARDA-supported product was in 2007 when a vaccine developed by Sanofi Pasteur became the first one licensed for the H5N1 influenza virus. Since then, BARDA support has led to 38 FDA-cleared uses for diagnostics and devices, 23 approved indications for treatments, and 23 licensed indications for vaccines.
BARDA helps companies get products through the most difficult phases of development and assists them across the regulatory finish line by providing guidance and expertise on oversight, clinical and non-clinical development, manufacturing, and quality and regulatory processes.
Recent public health responses have relied heavily on BARDA-supported products. More than one million vaccines and treatments developed and stockpiled for a smallpox emergency were used in the mpox response; BARDA-supported diagnostics, vaccines, and treatments were used during the COVID-19 pandemic and the global response to Ebola; and the response to the Zika virus relied on a BARDA-supported diagnostic to screen the U.S. blood supply.
“Since 2006, BARDA has supported the development of lifesaving medical countermeasures to protect Americans from public health emergencies,” said BARDA Director Gary Disbrow. “The 85th approval highlights our efforts to prepare against new and emerging threats, catalyze innovation in advanced research and development, and focus on strengthening the health security of our nation.”
The 85th product clearance is the QScout system, developed by Ad Astra Diagnostics (AAD). The QScout system includes the QScout RLD (Rapid Leukocyte Differential) test and the QScout Lab analyzer. This point-of-care hematology device uses image-based analysis on a small drop of blood to enumerate and classify white blood cells present in patient samples in approximately two minutes. This analysis can be performed in point-of-care settings which can assist health care workers so they can better manage patient care in settings both inside and outside the hospital. BARDA and AAD of Morrisville, North Carolina, initially partnered in 2021 to develop this new diagnostic system as part of BARDA’s Host-Based Diagnostics Program.
To see a full list of BARDA-supported product approvals and clearances, visit medicalcountermeasures.gov.
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