Some potential good news in the future. Quote from
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Posted On: 02/11/2021 6:48:40 PM
Some potential good news in the future. Quote from QMC Health ID on Twitter:
Tweet:
https://twitter.com/QMCHealthID/status/135998...23715?s=19
Article:
https://thehill.com/policy/healthcare/538349-...tests?rl=1
Notable Points in The Article:
“We are excited by the potential for at-home tests as a part of our COVID response national strategy and we all want to see them as quickly as possible,” Slavitt added in a statement to The Hill on Wednesday. “The best way for us to do that is to get out of the FDA’s way and let them do their jobs.”
One company working on rapid tests, Innova Medical Group, says it could be making millions of its tests available to the United States right now if the FDA would grant authorization. Instead, the company is making tests in a California plant and shipping them overseas.
“So California, actually, in an interesting way, is a net exporter of tests that the United States isn't using, because of the challenges with the FDA,” Daniel Elliott, the company’s CEO, said in an interview.
The California facilities will be able to make 5 million tests per day by the end of February, the company says.
“If the U.S. government today said, ‘OK, go,’ I could deliver 60 million tests before the end of February,” Elliott said.
The company first applied to the FDA in August, Elliott said, and has been facing a series of questions from the agency for months.
Asked about the Innova application, Shuren, the FDA official, responded broadly, emphasizing the need for solid data. "We consider tests for at-home use to be a top priority,” he said. “And if they've got their data and the data looks good, we authorize."
Lets hope Innova receives FDA authorization sometime in the near future.
Quote:
It looks like At-Home Covid-19 Tests are poised to take off. This is very exciting news for companies like QMC HealthID™ and Innova Medical. Please note that Innova is prominently and favorably featured in this article. Good news!
Tweet:
https://twitter.com/QMCHealthID/status/135998...23715?s=19
Article:
https://thehill.com/policy/healthcare/538349-...tests?rl=1
Notable Points in The Article:
“We are excited by the potential for at-home tests as a part of our COVID response national strategy and we all want to see them as quickly as possible,” Slavitt added in a statement to The Hill on Wednesday. “The best way for us to do that is to get out of the FDA’s way and let them do their jobs.”
One company working on rapid tests, Innova Medical Group, says it could be making millions of its tests available to the United States right now if the FDA would grant authorization. Instead, the company is making tests in a California plant and shipping them overseas.
“So California, actually, in an interesting way, is a net exporter of tests that the United States isn't using, because of the challenges with the FDA,” Daniel Elliott, the company’s CEO, said in an interview.
The California facilities will be able to make 5 million tests per day by the end of February, the company says.
“If the U.S. government today said, ‘OK, go,’ I could deliver 60 million tests before the end of February,” Elliott said.
The company first applied to the FDA in August, Elliott said, and has been facing a series of questions from the agency for months.
Asked about the Innova application, Shuren, the FDA official, responded broadly, emphasizing the need for solid data. "We consider tests for at-home use to be a top priority,” he said. “And if they've got their data and the data looks good, we authorize."
Lets hope Innova receives FDA authorization sometime in the near future.
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