DOD OTA Agreement Leveraged by Interagency for COVID-19 Rapid Response
Posted by: Press Release |
Mar 31, 2020 |
JPEO-CBRND uses existing OTA agreement with Cepheid, Inc., to support HHS/BARDA and address the global coronavirus threat.FORT DETRICK, Md.
– The Department of Defense (DOD), in conjunction with the Biomedical Advanced Research and Development Authority (BARDA) - part of the U.S. Department of Health and Human Services Office of the Assistant Secretary for Preparedness and Response (HHS ASPR) leveraged an existing Other Transaction Authority (OTA) agreement with Cepheid, Inc. to develop a rapid diagnostic test for the 2019 novel coronavirus (COVID-19).
The DOD’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND) Medical Countermeasures Development Consortium (MCDC) helped facilitate the relationship between the United States government and Cepheid, Inc.
Through this collaboration, Cepheid, Inc., has completed test optimization and validation activities, and on March 20, 2020, was officially granted Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) for use in the current COVID-19 outbreak. The FDA has the authority to allow the use of tests and other medical products during emergencies when no FDA-approved alternatives exist. This EUA will remain in effect for the duration of the COVID-19 declaration allowing emergency use of these diagnostics, unless terminated or revoked by the FDA.
The test is compatible across the Cepheid family of diagnostic systems – to include the GeneXpert® and Infinity platforms – intended for use in clinical and hospital laboratories, and able to rapidly deliver results within 45 minutes. Cepheid’s GeneXpert® is a proven diagnostic platform, used worldwide in both military and civilian health care facilities to test for other infections, including tuberculosis, HIV, Group A Streptococcus
(strep), and influenza.
To support this development work, the BARDA provided Cepheid with technical expertise and approximately $3.7 million in initial funding through the existing Cepheid/JPEO-CBRND OTA agreement; with additional funding planned as the program progresses.
“We are extremely pleased to assist BARDA in our nation’s effort to provide COVID-19 novel or emerging coronavirus diagnostic tests to our nation’s healthcare providers and public health officials,” said Mr. Douglas Bryce, Joint Program Executive Officer for CBRN Defense. “This collaboration is saving valuable time and dollars and is a testament to the work that the BARDA and JPEO-CBRND teams have and will accomplish together.”
While the DOD’s primary goal is to protect the warfighter, this initiative demonstrates the value of interagency collaboration to accelerate response efforts, allowing for wider placement and utilization of the COVID-19 test within the civilian health care system, and ultimately strengthening the public health response.
Read more about how this existing Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense’s (JPEO-CBRND)/Cepheid, Inc., OTA agreement is being leveraged to support the advanced development of this rapid diagnostic test for COVID-19 here: https://www.phe.gov/Preparedness/news/Pages/coronavirus-cepheid-22March20.aspx. About the JPEO-CBRND: The Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense is the Joint Service’s lead for development, acquisition, fielding and life-cycle support of chemical, biological, radiological, and nuclear defense equipment and medical countermeasures. As an effective acquisition program, the JPEO-CBRND puts capable and supportable systems in the hands of the service members and first responders, when and where it is needed, at an affordable price. Our vision is a resilient Joint Force, enabled to fight and win unencumbered by a chemical, biological, radiological, or nuclear environment, championed by innovative and state-of-the-art solutions. The Joint Project Manager for Chemical, Biological, Radiological, and Nuclear Medical (JPM CBRN Medical) is a component of the JPEO-CBRND and facilitates the advanced development and acquisition of medical countermeasures and systems to enhance the nation’s biodefense response capability.