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Medical Research Institute Develops Ebola Diagnostics

By Cheryl Pellerin DoD News, Defense Media Activity

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WASHINGTON, Oct. 27, 2014 — The Ebola crisis in West Africa seized global attention in March, but scientists at the U.S. Army Medical Research Institute of Infectious Diseases have worked for years on diagnostics, vaccines and drugs for Ebola and other lethal pathogens that adversaries might use in bioweapons targeting troops on the battlefield.

USAMRIID, based in Frederick, Maryland, has pioneered research since 1969 to develop such medical countermeasures, and its work has contributed to critically needed help in the current outbreak.

On Oct. 25, the World Health Organization reported 10,141 cases of confirmed and suspected Ebola virus disease in six affected countries -- Guinea, Liberia, Mali, Sierra Leone, Spain, and the United States -- and in the previously affected countries of Nigeria and Senegal, and 4,922 deaths, all as of Oct. 23.

During a DoD News interview last week, a USAMRIID scientist discussed the institute’s work on Ebola diagnostics, a critical tool that allows medical workers in West Africa, and now around the world, to determine whether someone is infected with the Ebola Zaire virus.

The Ebola Zaire strain, one of four known strains of Ebola virus, is the one that has caused the current outbreak.

Diagnostics, vaccines, therapeutic drugs needed

In Africa today, some of the most-needed medical products are diagnostics, vaccines and therapeutic drugs to treat Ebola virus disease. USAMRIID and others are working on vaccines and therapeutics for Ebola, but none has been approved yet for use in patients.

Diagnostic assays developed at USAMRIID, however, are being used now in Africa to detect the Ebola virus in patient whole blood, serum or plasma samples. And beyond its vaccine and therapeutic efforts, USAMRIID has several efforts contributing directly to fighting the Ebola crisis in West Africa, said Dr. David Norwood, chief of the institute’s diagnostics systems division.

“That includes providing a diagnostic capability to the host nation in support of diagnosing Ebola on the continent,” he said, “[and] we’ve worked with the [Food and Drug Administration], the Joint Program Executive Office and others to get an emergency use authorization for the same assay for testing American citizens.”

Emergency-use declaration

On Aug. 5, FDA issued an emergency-use authorization for the Defense Department’s real-time polymerase chain reaction assay for Ebola.

FDA officials said the authorization was based on a 2006 Department of Homeland Security declaration that the Ebola virus even then “presented a material threat against the U.S. population sufficient to affect national security.”

The 2006 DHS declaration said the circumstances justified the emergency use of diagnostic tests to detect Ebola. Also on Aug. 5, Homeland Security Secretary Sylvia Mathews Burwell determined that circumstances exist to justify authorizing the emergency use of diagnostics for detecting Ebola virus disease.

Norwood said the assay is available for troops deploying to West Africa and to U.S. citizens through U.S. Public Health laboratories and the Centers for Disease Control and Prevention.

“The assays typically are designed to pick up either proteins or nucleic acids from the virus, or in some cases the host, and the idea is to detect the presence of the virus in bodily fluids, typically of someone who is infected,” he added. “Critical to a diagnostic test is the ability to detect the organism very early.”

Early signs of Ebola similar to those for flu

Early signs of Ebola are similar to early signs of other fever-producing illnesses such as flu, so the test is important in identifying Ebola early so those infected can be quarantined, Norwood explained.

Scientists and technical staff from USAMRIID have been in Liberia since March of last year providing diagnostic capabilities, the doctor said.

“Beginning in August of this year,” he added, “we have had teams … on the ground assisting, USAMRIID and [National Institutes of Health] personnel, providing diagnostic assays to folks in the Monrovia area of Liberia.” The Naval Medical Research Center has two field-deployed teams operating in Monrovia as well, he said.

Training for military personnel, foreign governments

USAMRIID also provides training for military personnel in a course called Field Identification of Biological Warfare Agents, and Norwood said the institute has hosted representatives from foreign governments to train on using diagnostic capabilities in the field.

“For this particular outbreak, we have tailored a specific training program at USAMRIID that involves being able to perform the laboratory tests in the appropriate [personal protective equipment],” he noted, adding that USAMRIID personnel have trained the Liberian staff that works alongside them in the proper use of personal protective equipment and the performance of the assays.

Norwood said USAMRIID also is involved in developing protocols for some of the assays USAMRIID is required to support. These include assays that will be required, for example, in future clinical investigations to test the level of a new drug in patients’ blood.

As the diagnostic field advances, Norwood said, the main focus will be to drive disease identification very close to, if not at, the time symptoms appear. “There's a significant effort through the Joint Science and Technology Office to invest in methods that could identify the response of the host to infection,” he added.

Moving forward in diagnostics

Even something as basic as being able to determine whether someone has a viral or bacterial infection by looking at one impact of the infection on the host response would be a huge step forward for clinical treatment, Norwood said.

“That would drive the decision about whether to provide antibiotics for somebody, for example,” he explained. “That's where diagnostics is moving -- to try to diagnose before the level of virus or bacteria … [gets] to a critical level in order to identify the presence of the organism.”

In response to a question about the nature of USAMRIID’s contribution to the West Africa Ebola crisis, Norwood said USAMRIID and its experts have been working on pathogens like Ebola virus for many years before the current outbreak. “We had started in 2010 preparing the documentation for all the filoviruses that include Ebola and Marburg, to submit it to the FDA for just such an event,” he explained.

The process is called a pre-EUA submission, and USAMRIID experts provided data to FDA so that if a dangerous outbreak occurred, the FDA could quickly transition the diagnostics into use under an emergency declaration.

Determining likelihood of emergency outbreaks

At the time, Norwood said, USAMRIID submitted 73 assays to the FDA and engaged several subject-matter experts to try to determine which of the assays would be critical for emergency outbreaks.

“Time and time again,” Norwood said, “the filoviruses came up as the No. 1 priority, so we were … concerned about this.”

He added, “I don't think I can sit here and honestly say we were ready for what has happened. But we were certainly more prepared than we would have been.” And that's what USAMRIID tries to do, he added -- predict and be ready for that next event.

USAMRIID is uniquely positioned with therapeutic, vaccine and diagnostic medical countermeasure capabilities all under one roof, with biocontainment capabilities, Norwood said, for the lethal pathogens.

“And while we've got U.S. Army in our name,” he added, “the solutions we work on are solutions that can impact public health. I think we're seeing the effects of what we do on public health in the current outbreak.”

(Follow Cheryl Pellerin on Twitter @PellerinDoDNews)