In a story first appearing in the New York Times and authored by Sheila Kaplan, the Food and Drug Administration (F.D.A.) has granted emergency clearance for a testing kit developed by a company named “Everlywell.” The Everlywell kit allows consumers to harvest a nasal sample and send it into a laboratory for diagnosis.
Dr. Jeffrey Shuren, director of the F.D.A.’s Center for Devices and Radiological Health, in a released statement, said the new test provides increased patient access to tests while protecting others from exposure. Health care workers, under the test presently administered assuming one gets access to testing in the first place, risk infection while administering the diagnostic tool.
The kit will contain a swab for individuals to use to take a sample from inside their nostrils. The kit will also have a saline solution filled tube into which the person being tested will deposit the swabs.
The subject will then have to send the contents to one of two facilities, Fulgent Therapeutics or Assurance Scientific Laboratories. The plan going forward is for Everlywell to partner with additional labs.
Some public-health researchers warn the at-home nasal test may be less accurate than the specimen collected by health care providers. The test now involves the insertion of a long nasal swab through the nose into the back of the throat.
A spokeswoman for Everlywell said consumers will take an online screening survey to determine whether they meet federally imposed guidelines for self-administering the at-home test versus being tested at a health-care facility. Provided the consumer qualifies for the at-home test, one will be shipped out immediately.
Everlywell used studies and leveraged data supported by the Bill and Melinda Gates Foundation and UnitedHealth Group to gain F.D.A. approval. Everlywell makes a variety of products one can buy, both online and in stores, which include other in-home testing kits. These other Everlywell kits test for diabetes, sexually transmitted disease, and high-cholesterol.
Everlywell was among several businesses drawing negative attention from members of Congress in March of this year. They were accused of entering the market for coronavirus testing kits without having first sought F.D.A. approval. This was an error the company didn’t repeat this time.
The spokeswoman for Everlywell said consumers will get the test from three to five days after hitting the “order” button. These kits will not be free and one wonders if the charge, per kit, is what one would term “affordable.”
The kits will be available by the end of May. They will cost $135.00 each.