FDA approves use of South Korean coronavirus tests purchased by Maryland’s government

The U.S. Food and Drug Administration has approved a South Korean company’s coronavirus tests for use in the United States, clearing one key hurdle for Maryland officials to begin ramping up deployment of the 500,000 tests they acquired.

“I am authorizing the emergency use of your product,” wrote Rear Adm. Denise M. Hinton, chief scientist of the Food and Drug Administration, in a Wednesday letter to Myoung Shin Kim, research and development manager of South Korean firm LabGenomics Co.


“It is reasonable to believe ... the known and potential benefits of your product when used for diagnosing COVID-19, outweigh the known and potential risks of your product.”

Ten days ago, Republican Gov. Larry Hogan announced the purchase of test kits from LabGenomics that he touted as "an exponential, game-changing step forward on our large-scale testing initiative.” The nearly $9.5 million purchase was lauded on national TV, with Hogan making numerous appearances on programs ranging from ABC’s “The View” to “The Daily Show” on Comedy Central.


Since then, some local governments, nursing homes, unions and others in Maryland have clamored for the tests, but say they’ve come up empty-handed so far.

“We’ve been asking, ‘Where are the tests? Where are the tests?'” said Patrick Moran, president of the American Federation of State, County and Municipal Employees Maryland Council 3 union, which represents correctional officials, hospital workers and other state employees. “The governor took a victory lap before finishing the job. It is disheartening the governor sees no rush and no urgency to test the facilities where his own employees work.”

After announcing the purchase of the tests April 20, Hogan was asked at a State House news conference whether the tests were ready to be deployed. The governor cautioned then that it would take some time to match the tests with necessary supplies, such as swabs, reagent and lab capacity.

“They don’t have everything that’s needed," Hogan said. “You need the lab capability. You need the swabs. You need the reagents, and they all have to kind of work together. ... It’s going to take a while to ramp up all of the things that we need to utilize all of the tests.”

Mike Ricci, a spokesman for Hogan, said the state received preliminary FDA approval last week to use the tests from South Korea, but he was glad to see the formal approval that the FDA sent this week to the test manufacturer.

“While Maryland already received FDA approval to begin using these tests last week, and have begun deploying these tests for our high-priority clusters and outbreaks, this is certainly good news," Ricci said Thursday.

To date, Ricci said, he didn’t know how many of the Korean tests have been used, but he said they were being deployed to “high-priority hot spots such as nursing homes, drive-thru sites, and the new testing site in Salisbury for poultry processing plant workers.”

Hogan ordered on Wednesday universal coronavirus testing at nursing homes and assisted-living facilities after hundreds of deaths at those sites and calls on state government to better protect its most vulnerable residents. Meanwhile, an outbreak among poultry workers on the Eastern Shore has made Salisbury the state’s newest hot spot.


Ricci said the state still was increasing its supply of other materials needed to use more of the tests. For instance, Maryland received 34,000 swabs from the strategic national stockpile of emergency supplies and the state lab has roughly 6,000 swabs. He added that each of the state’s private lab partners has about 20,000 swabs to conduct tests.

As for reagent, Ricci said, “we have adequate supply to run tests for several weeks and anticipate more reagent becoming available.”

State Del. Eric Luedtke, a Montgomery County Democrat who is the House of Delegates majority leader, called FDA approval of the Korean tests “a win for Marylanders, so desperately in need of COVID testing.”

“I’m hopeful that we now have all of the components necessary to fully deploy these kits to hospitals, nursing homes, state agencies, and all Marylanders can make full use of these kits,” Luedtke said. “If not, I would ask the governor to provide a full accounting and schedule of when these critically important resources will be actually usable.”

In a livestreamed interview Thursday with The Washington Post, Hogan said the 500,000 tests are part of a long-term strategy for testing in the state, and they were never intended to be used “in the first week we acquired them."

"Right now, we’re using all we can possibly use,” said Hogan, adding that he hopes the state can keep up with test demand.


When Maryland officials arranged for the shipment from South Korea, they took steps to avoid the possibility of the federal government seizing or delaying the shipment, the Hogan administration has said.

Maryland officials arranged for the Korean Air plane to land at BWI Thurgood Marshall Airport in Linthicum ― which the airline doesn’t usually serve ― instead of Washington Dulles International Airport in northern Virginia.

"We landed there with a large contingent of Maryland National Guard and Maryland State Police because it was an enormously valuable payload,” Hogan said in the Post interview. “It was like Fort Knox to us.”

Once the tests landed, Hogan said they were taken to an undisclosed location, protected by Guard members and state troopers.

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Howard County Executive Calvin Ball said that he’s appreciative of the “innovative approach” Hogan used to buy the tests.

Ball, a Democrat, said he understands the state has priorities and needs swabs and reagents to fully deploy the tests.


“Howard County continues to coordinate with state officials to finalize acquisitions of the tests,” Ball said in a statement. “Once we receive this increased supply, we are ready to immediately expand our operations locally.”

Lester Davis, a spokesman for Baltimore Mayor Bernard C. “Jack” Young, a Democrat, called the purchase of tests from South Korea an “A+ move.”

“It was coup for the state to get half a million of these tests. Of course, you have to make sure you have clearance to use them and you get the swabs and other supplies,” Davis said. “As soon as they’re able to be disbursed, Baltimore City is ready to take as many tests off the state’s hands as humanly possible.”

Baltimore County Executive Johnny Olszewski Jr., a Democrat, is waiting to hear about a time frame for when some of the tests might come to his county, according to his spokesman Sean Naron.

“The test kits from South Korea are just a piece of the puzzle and we still need the appropriate swabs, reagents and lab capacity,” Naron said in a statement Thursday. “We are still waiting on a clear timeline from the state on when all these pieces will come together.”