A rapid diagnostic test for novel coronavirus infections 2019 (COVID-19) has received advanced development support through a collaboration between the U.S. Department of Health and Human Services (HHS), the U.S. Department of Defense (DoD), and Cepheid of Sunnyvale, California.
As part of this collaboration, Cepheid completed optimization and validation of the test, and the test was granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) for the current coronavirus outbreak.
The test is developed for use on Cepheid’s GeneXpert diagnostic platform which is used world-wide to test for other infections, such as tuberculosis, HIV, Group A Streptococcus (strep), and influenza. The COVID-19 test can provide results within 45 minutes, and is designed for use in clinical and hospital laboratories.
To support this development work, the Biomedical Advanced Research and Development Authority (BARDA), part of the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR), will provide Cepheid with technical expertise and approximately $3.7 million in initial funding by using an existing agreement between the company and the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological, and Nuclear Defense (JPEO-CBRND). Additional funding is planned as the program progresses.
“Diagnostics that provide rapid results at the point-of-care are essential to healthcare professionals in making treatment decisions, to patients in guiding their actions to curb the spread of infections, and to public health officials in their community-based efforts to mitigate coronavirus outbreaks,” said BARDA Director Rick A. Bright, Ph.D. “We have been working quickly with counterparts across the U.S. government to identify potential products for advanced development, and we are grateful to the JPEO and Cepheid for collaborating with us to move this forward.”
“As part of our mission to protect soldiers, sailors, airmen and Marines from CBRN threats, the JPEO-CBRND works with the private sector to develop and modernize diagnostics capabilities against biological threats. Through leveraging expertise across the government, both the efforts and outcomes achieve greater success,” said Mr. Douglas Bryce, Joint Program Executive Officer for CBRN Defense. “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. This collaboration is saving valuable time and dollars and it is a testament to the work that the BARDA and JPEO-CBRND teams have and will accomplish together.”
JPEO-CBRND has worked with Cepheid over the past 18 months to develop military relevant tests for hemorrhagic and tropical fevers to diagnosis biothreat and syndromic endemic diseases of operational concern.
In addition to developing a COVID-19 test, future collaboration between BARDA, JPEO-CBRND and Cepheid could include a diagnostic test on the GeneXpert platform that can detect and differentiate known human coronaviruses and detect novel or emerging coronaviruses. Such a test could alert healthcare providers and public health officials quickly of future outbreaks involving new coronaviruses, giving them valuable time to take action that could limit the spread of a new disease.
FDA issued emergency use authorization for diagnostic tests from the Centers for Disease Control and Prevention (CDC) and other authorized public health laboratories, and for use of New York State’s Wadsworth diagnostics test. In addition, FDA also issued a new policy Feb. 29 to help expedite the availability of diagnostics.
HHS continues to work across the U.S. government, including with the Department of Defense, to review potential products from public and private sectors to identify promising candidates that could detect, protect against or treat COVID-19 for development and licensure. HHS divisions, including the National Institutes of Health (NIH) and ASPR, have begun supporting development of multiple vaccines and potential therapeutic treatments for COVID-19.
To obtain information about any potential products in development in the private sector that could be used in responding to the novel coronavirus outbreak, the U.S. government launched a single point-of-entry website for innovators and product developers to submit brief descriptions of their diagnostics, therapeutics, vaccines, and other products or technologies being developed for COVID-19.
To shorten the time to apply for product licensure and to reduce the spread of COVID-19, federal agencies are particularly interested in identifying products and technologies that have progressed beyond non-clinical studies, have established domestic large-scale manufacturing capability with commercial Good Manufacturing Practices (cGMP), and have utilized a platform used to manufacture a product already approved by the FDA.
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 ASPR is to save lives and protect Americans from 21st century health security threats. Within ASPR, BARDA invests in the innovation, 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. To date, 54 BARDA-supported products have achieved regulatory approval, licensure or clearance.
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, we put 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.