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GOVERNOR LARRY HOGAN CALLED IT A GAME CHANGING DEAL,THE PURCHASE BY THE STATE OF HALF A MILLION CORONAVIRUS TESTS, MADE BY SOU KOREAN COMPANY LABGENOMICS. THE FIRST SHIPMENT ARRIVED APRIL 18 VIA A KOREAN AIR JET AT BWI. TWO DAYS LATER, THE GOVERN SAID THE COMPANY HAD ALREADY BEEN WORKING TO VALIDATE ITS TESTS BY THE TIME THE PLANE ARRIVE >> WE HAVE ALREADY DONE THE PROTOCALS AND TESTING AND THE LABS HAVE BEEN WORKING TOGETHER , SO THIS IS A LONG TERM TESTING STRATEGY. JAYNE: AS OF YESTERDAY, THERE HAD BEEN NO REVIEW OF THE COMPANY’S TESTS BY THE FDA. THE NOTIFICATION TO THE FDA THE COMPANY HAD TESTED AND WAS DISTRIBUTING ITS TEST KITS IN MARYLAND, CAME JUST THE DAY BEFORE THE PLANE ARRIVED, APRIL 17. THE COMPANY USED AN EMERGENCY RULE ISSUED BY THE FDA, THAT ALLOWS A COMPANY TO DISTRIBUTE ITS PRODUCT WITHOUT FDA APPROVAL. ACCORDING TO AN FD SPOKESPERSON’S STATEMENT TO US MONDAY, THE FDA HAS NOT YET REVIEWED LABGENOMICS’ VALIDATION ABOUT ITS TEST 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 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 JAYN THIS MORNING I ASKED THE SPOKESPERSON FOR THE GOVERNOR’S OFFICE, AND THREE SPOKES PEOPLE FOR THE STATE HEALTH DEPARTMENT, IF THE STATE INTENDED TO DISTRIBUTE THESE TESTS WITHOUT THE FDA’S REVIEW FOR APPROVAL. AND, IF ANY OF THESE TESTS THAT WERE PURCHASED FROM THE SOUTH KOREAN COMPANY HAD BEEN DISTRIBUTED AT THIS POINT. AT THIS HOUR, I HAVE RECEIVED NO RESPONSE FROM ANY OF THE

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There are new questions about the coronavirus tests Maryland procured from South Korea and their status with the Food and Drug Administration.|| Coronavirus updates | Maryland's latest numbers | Rumor Control ||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 evening, Mike Ricci, a spokesman for Hogan, issued a statement: "The FDA cleared these tests to come into the country, they have been validated by the lab, and we have completed the necessary study to begin using them as part of our expanded testing capacity to slow the spread of COVID-19 in Maryland. We are grateful to the federal administration for working with us to expedite these critical tests that will help save lives."