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Home diagnostics startup Everlywell is launching an at-home coronavirus test sample kit

Home diagnostics startup Everlywell is launching an at-home coronavirus test sample kit”

The U.S. Food and Drug Administration on Wednesday approved a new test kit for coronavirus.

The March 16 policy could be the biggest revision yet. "At this time, the FDA is focused on making sure tests are distributed and that test developers and labs have the materials they need to run the tests". The Guidance contains policies regarding (i) laboratories' development and use of certain tests prior to or without an Emergency Use Authorization (EUA), (ii) commercial manufacturers' development and distribution of certain tests prior to an EUA, and (iii) development, use, and distribution of serological tests without an EUA.

Under the second prong, each state may authorize laboratories within its territory to develop and use SARS-CoV-2 diagnostic tests without notifying FDA of test validation and without engaging in the EUA process. Under the February 29 guidance, the FDA granted EUA waivers to labs that are certified to perform high-complexity testing, but commercial vendors were not covered by that policy. The agency said that while serological tests are less complex than molecular tests and only identify antibodies, it does not intend to object to vendors developing these tests for SARS-CoV-2 infection.

With respect to allowing states to regulate diagnostics, Hahn said that the policy would only extend to those states that wish to take on oversight themselves, like NY.

More news: Indians overseas infected with coronavirus, Centre tells Parliament

At the moment, it's not known how many test kits are now available as "this number fluctuates daily as more and more test developers get their tests in the field and start testing patients", the FDA said in their Monday statement.

"This change will quickly afford Co-Diagnostics even more opportunities to serve the needs of laboratories nationwide, as we play an even larger role in responding to this pandemic", he said.

Since the end of January, the FDA has being working with more than 100 diagnostic test developers. However, it should be noted that the manufacturer may have to suspend distribution and recall its products if, upon review of the EUA request, FDA identifies a significant problem that can not be addressed in a timely manner. The FDA will then review this data.



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