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FDA green-lights DoD Ebola diagnostic
September 2014
by Kelsey Kaustinen  |  Email the author
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SILVER SPRING, Md.—The U.S. Food and Drug Administration (FDA) has authorized the use of an Ebola diagnostic test in order to combat the recent outbreak affecting West Africa. The test, known as the DoD EZ1 Real-time RT-PCR Assay, is approved for use abroad on military personnel, aid workers and emergency responders in laboratories designated by the Department of Defense (DoD) to respond to the outbreak.
 
“The test is designed for use in individuals, including Department of Defense personnel and responders, who may be at risk of infection as a result of the outbreak,” Stephanie Yao, FDA spokeswoman, commented in a statement. “Specifically, the test is intended for use in individuals with signs and symptoms of infection with Ebola Zaire virus, who are at risk for exposure to the virus or who may have been exposed to the virus.”
 
The FDA issued an Emergency Use Authorization on August 5 to authorize the use of the assay in Trizol-inactivated whole blood or Trizol-inactivated plasma specimens. This move stems from a 2006 decision by then-Secretary of the Department of Homeland Security Michael Chertoff that “pursuant to section 319F-2 of the Public Health Service Act (42 U.S.C. § 247d-6b), that the Ebola virus presents a material threat against the United States population sufficient to affect national security,” as noted in an FDA news release.
 
In a supplemental fact sheet for healthcare providers regarding the Ebola Zaire test, the FDA noted that “The test does not indicate the stage of infection, nor does it distinguish between different Ebola Zaire virus strains.” Additionally, while “The EZ1 rRT-PCR Assay has been designed to minimize the likelihood of false-positive test results,” it was noted in a similar fact sheet for patients that “there is a very small risk that the test result reported is incorrect.”
 
The U.S. Centers for Disease Control and Prevention (CDC) have established a page to track developments and case counts for the West Africa Ebola outbreak, and according to that source, as of August 22, there was a suspected and confirmed case count of 2,615, 1,528 laboratory-confirmed cases and 1,427 suspected case deaths. Roughly 55 to 60 percent of those who have been infected have died in the outbreak, according to the CDC. This is one of the largest outbreaks of the disease in recorded history, the organization notes, and the first in West Africa. Four countries are afflicted in this outbreak so far: Liberia, Nigeria, Sierra Leone and Guinea.
 
While a number of vaccines are under development, they are all in the very early stages, and as such, it is not likely a successful vaccine will be available until 2015. The experimental vaccine that is currently most advanced was designed by the Vaccine Research Center, an arm of the National Institutes of Health (NIH). Phase 1 trials of the vaccine are set to begin in late September and conclude in January. Crucell is also developing a vaccine for Ebola, as is Profectus Biosciences, and the NIH is supporting both efforts. The NIH also noted that it is working with Thomas Jefferson University to develop a vaccine candidate based on the existing rabies vaccine.
 
ZMapp, an experimental drug being developed by Mapp Biopharmaceutical Inc., was given to two American aid workers who were infected in Liberia, with initially promising responses. The drug is a combination of three monoclonal antibodies and is intended to be administered to patients shortly after infection.
 
The U.S. Department of Health and Human Services noted in a statement that “Tekmira and BioCryst Pharmaceuticals receive funding from the Department of Defense’s Defense Threat Reduction Agency and have therapeutic candidates for Ebola in early development … The Department of Defense is working with a company called NewLink to develop an Ebola vaccine candidate. BioCryst, with NIH support, is working to develop an antiviral drug to treat Ebola virus that is expected to begin Phase 1 testing later this year.”
 
Diagnostic test developer Corgenix Medical Corp. is also joining the effort, having begun work on a $2.9-million grant from NIH in June. The grant was awarded to Corgenix and members of the Viral Hemorrhagic Fever Consortium, a collaboration of industry and academic members led by Tulane University, to support the development of rapid diagnostic tests for Ebola. Corgenix is the principal investigator for the new NIH-funded contract to complete development of recombinant diagnostic tests for Ebola.
 
Code: E091423

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