FROM YAHOO BOARD How does this happen.
Maryland Gov. Larry Hogan touted what he called a secret deal with a company in South Korea to acquire badly needed coronavirus test kits. The question now has become, will the state allow the tests to be used without review by the FDA?
The governor called it a game-changing deal in announcing the purchase by the state of 500,000 coronavirus tests made by South Korean company LabGenomics. The first shipment arrived April 18 via a Korean Air jet at Baltimore-Washington International Thurgood Marshall Airport.
Two days later, the governor said the company had already been working to validate its tests by the time the plane arrived.
"We have already done the protocols and testing, and the labs have been working together, so this is a long-term testing strategy," Hogan said on April 20.
As of Monday, there had been no review of the company's tests by the FDA. The notification to the FDA that the company had tested and was distributing its test kits in Maryland came April 17, the day before the plane arrived.
The company used an emergency rule issued by the FDA that allows a company to distribute its product without FDA approval.
An FDA representative sent a statement to the 11 News I-Team on Monday, saying: "The FDA has not yet reviewed LabGenomics' validation about its tests."
LabGenomics is not on the FDA's list of companies that have been given emergency use authorization to distribute test kits. To date, there are 49 such companies that sell test kits. That list has been growing since the second week of March.
The FDA has said its goal is to expand testing capacity while, at the same time, ensuring tests are accurate.
Tuesday morning, the 11 News I-Team asked the spokesperson for the governor and three spokespeople for the Maryland Department of Health if the state intended to distribute the tests without review by the FDA for approval, and if any tests have been distributed. A response has not yet been received.
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Maryland Gov. Larry Hogan touted what he called a secret deal with a company in South Korea to acquire badly needed coronavirus test kits. The question now has become, will the state allow the tests to be used without review by the FDA?
The governor called it a game-changing deal in announcing the purchase by the state of 500,000 coronavirus tests made by South Korean company LabGenomics. The first shipment arrived April 18 via a Korean Air jet at Baltimore-Washington International Thurgood Marshall Airport.
Two days later, the governor said the company had already been working to validate its tests by the time the plane arrived.
"We have already done the protocols and testing, and the labs have been working together, so this is a long-term testing strategy," Hogan said on April 20.
As of Monday, there had been no review of the company's tests by the FDA. The notification to the FDA that the company had tested and was distributing its test kits in Maryland came April 17, the day before the plane arrived.
The company used an emergency rule issued by the FDA that allows a company to distribute its product without FDA approval.
An FDA representative sent a statement to the 11 News I-Team on Monday, saying: "The FDA has not yet reviewed LabGenomics' validation about its tests."
LabGenomics is not on the FDA's list of companies that have been given emergency use authorization to distribute test kits. To date, there are 49 such companies that sell test kits. That list has been growing since the second week of March.
The FDA has said its goal is to expand testing capacity while, at the same time, ensuring tests are accurate.
Tuesday morning, the 11 News I-Team asked the spokesperson for the governor and three spokespeople for the Maryland Department of Health if the state intended to distribute the tests without review by the FDA for approval, and if any tests have been distributed. A response has not yet been received.
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