Army researchers seeking FDA approval for expanding use of monkeypox test

Brian Kearney, Research Microbiologist, harvests samples of coronavirus in a Biosafety Level 3 laboratory at the U.S. Army Medical Research Institute of Infectious Diseases at Fort Detrick, Md. This virus stock will be used to develop models of infection for coronavirus, as well as diagnostic tests, vaccines and therapeutics. USAMRIID, established in 1969, is the Department of Defense’s lead laboratory for medical biodefense research.

Angela Roberts

The Frederick News-Post, Md.

(TNS)

Oct. 13—U.S. Army researchers in Frederick are working to get approval from the U.S. Food and Drug Administration to expand where their monkeypox diagnostic tool can be used.

Currently, the test — which determines whether a patient has been infected with the monkeypox virus — can only be operated in laboratories run by the United States Army Medical Research Institute of Infectious Diseases at Fort Detrick.

But if researchers receive an emergency use authorization from the FDA, they could set the test up at other laboratories run by the U.S. Department of Defense, said William Dorman, who runs the Special Pathogens Lab at USAMRIID.

“Instead of them having to package up a sample, get it shipped out to us, wait for us to test it, get the results back,” Dorman said, “we could potentially pre-position the [test] at their laboratory. And then they could run it right there, as soon as they had a sample, and get a result.”

Before this year, monkeypox — an infectious disease caused by a virus similar to the one that causes smallpox — was rarely reported in the United States.

But USAMRIID researchers had already created a diagnostic tool for the virus when it started spreading in the U.S. in May.

With monkeypox already endemic in several countries in West and Central Africa, Army researchers developed a test in the early 2000s to track the spread of the virus, said Jeffrey Koehler, a branch chief in the Diagnostic Systems Division at USAMRIID.

Though scientists updated and refined the test over the years as technology became more advanced, it was used for research purposes, rather than clinical ones. Results weren’t used to help guide the treatment of patients.

But when the virus started spreading in countries where it wasn’t endemic, such as the U.S., USAMRIID researchers began testing the diagnostics tool to see whether it could be used to diagnose specific patients.

Col. Kurt Schaecher, who directs the clinical laboratory at USAMRIID, verified the accuracy of the data collected. The lab started accepting samples in August.

So far, the lab has only tested around a dozen samples, Dorman said, and only from medical treatment centers run by the Department of Defense.

But, he added, if the U.S. Centers for Disease Control and Prevention became overwhelmed by a surge in possible monkeypox cases, the lab would help the federal agency test samples.

That hasn’t been necessary yet, he said, and hopefully things will stay that way.

The number of monkeypox cases reported each week in the United States has declined regularly since August, according to CDC data. Since May, there have been 27,022 cases identified in the country, including 687 in Maryland.

The Maryland Department of Health, in its breakdown of cases by county, does not list a specific count in jurisdictions with fewer than 10 cases. Frederick County is one of those jurisdictions.

The monkeypox test used by state health departments answers two questions, Dorman explained. The first is whether the patient is infected with an orthopoxvirus — a genus that includes monkeypox, cowpox, smallpox and other pox viruses.

And second: Is the patient infected with smallpox?

“Because everybody’s really concerned about variola,” Dorman said, referring to the virus that causes smallpox. “If we have an outbreak of variola, we’re in trouble.”

But unlike the test used by state health departments, the one USAMRIID developed — and the one the CDC uses — can answer the specific question of whether a patient has monkeypox.

The CDC test can also determine whether a patient is infected with the monkeypox strain from West Africa, which is the one causing the current U.S. outbreak, or the Central African strain, which is more severe.

The USAMRIID test currently can’t differentiate between strains, but Army researchers are working to create a test that can, Dorman said.

The Special Pathogens Lab is run by a small team, which includes Dorman, another civilian scientist, and Sgt. Yuting Yang, who is the only soldier trained to test samples for monkeypox.

Dorman said Yang has played a key role in collecting data, so that USAMRIID can receive the Emergency Use Authorization for the test, coming in on nights and weekends to test samples.

“I’m pretty honored to be part of the team,” Yang said. “I didn’t think it would be a really big deal, but now that I’m thinking about it, we are really supporting the country.”

Follow Angela Roberts on Twitter: @24_angier

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