Economy

FDA authorizes Everywell at-home COVID-19 test

FDA authorizes Everywell at-home COVID-19 test”

The test kits are then sent to one of two labs now authorized under separate EUAs for COVID-19 testing, and the administration notes that this could expand to other test providers in future should they file for an EUA and provide the requisite data that goes along with the verification required for that emergency approval.

Testing by the Seattle Coronavirus Assessment Network (SCAN) was halted Thursday after a request from the Food and Drug Administration (FDA), which stated SCAN needed additional federal authorization to continue the program. The tests are categorized as surveillance tests, which can be used by researchers but cannot be given to patients or doctors for diagnostic purposes.

Made by startup Everlywell, the kit is the only one that can be used with multiple coronavirus tests, Axios reported. The company plans to partner with additional laboratories.

The at-home test will use a nasal sample to test for the virus.

The test kits will be available later this month, according to Ms. Song, and will cost $135. After the notice from the FDA, the program is prohibited from both accepting new tests and providing those who have already taken the test with results.

More news: Coronavirus Can cause 28 million cancelled Operations Internationally

"From the moment that you hit the order button, to the moment that you get the test results on your phone or device, that process is created to take three to five days", Ms. Song said.

Everlywell makes a variety of products that individuals can buy online or in stores, among them at-home test kits for diabetes, sexually transmitted diseases and high cholesterol.

Two tests have been authorised for checking samples gathered with the Everlywell device, and others may get the green light, the FDA said.

Once patients self-swab to collect their nasal sample, they will ship the sample overnight to a specific CLIA-certified lab that is running one of the in vitro diagnostic molecular tests. The other, developed by a Rutgers University laboratory, called RUCDR Infinite Biologics, in partnership with Spectrum Solutions and Accurate Diagnostic Labs, is for collecting a saliva sample.



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