Governor: NMI test kits now FDA-approved

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GOVERNOR Ralph DLG Torres on Tuesday announced that the test kits used for the community-based testing initiative are now FDA-approved.

Torres said the U.S. Food and Drug Administration issued an emergency use authorization or EUA to SolGent company, manufacturer of the DiaPlexQ novel coronavirus detection kit.

It is designed to detect SARS-CoV-2 in nasopharyngeal swabs, oropharyngeal (throat) swabs, anterior nasal swabs, mid-turbinate nasal swabs, nasal aspirates, nasal washes, bronchoalveolar lavage fluid, and sputum from individuals.

In a May 21 letter to SolGent, the FDA stated that the product met the criteria for the issuance of an EUA.

The FDA further concluded that based “on the totality of scientific evidence available…it is reasonable to believe that your product may be effective in diagnosing Covid-19, and that the known and potential benefits of your product when used for diagnosing Covid-19, outweigh the known and potential risks of your product.”

Moreover, the FDA said, there is “no adequate, approved, and available alternative to the emergency use of your product.”

The CNMI has acquired more than 60,000 test kits from the South Korean company.

They “went through the FDA process and got approved,” Commonwealth Healthcare Corp. Chief Executive Officer Esther Muna said.

She added there are still a lot of test kits available, so CHCC and the governor’s task force are now drawing up plans to ensure that everyone in the community will get tested.

Patrick Guerrero, the governor’s authorized representative, said the issuance by the FDA of an EUA on test kits means that the CNMI will be reimbursed by the Federal Emergency Management Agency. 

“There is no question now in terms of reimbursable expenses,” he added. “These test kits were approved by FEMA, and now with the EUA, the labor and equipment and testing expenses related to the community-based test will be covered by FEMA.”

Red to Yellow

Following consultations with local and federal agencies, the governor on Monday announced that the CNMI had moved from community vulnerability level “Red” to “Yellow.”

These included CHCC, the Centers for Disease Control and Prevention, the U.S. Department of Health and Human Services, the U.S. Department of Defense, and FEMA.

“These are all partners that collaborated with us in making the decision to open and what business to open,” the governor said. “I strongly believe that we are moving in the right direction and at the right pace.”

Muna said under vulnerability level “Yellow,” restrictions are still in effect, and stricter directives could be reimposed.  “It depends on the testing and the amount of negative results,” she added.

Before the governor’s announcement, she said, CHCC had to look at the restrictions that were in place and determine those that could be lifted.

“It took a lot of thinking because we want to ensure that members of the public will remain safe,” she added.

Muna said the message has not changed: “keep distance at least six feet apart; wash your hands; and wear a face mask.”

She also expressed appreciation to the private sector for observing social distancing protocols at business establishments.

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