The Food and Drug Administration on Saturday granted emergency clearance for a coronavirus testing kit that will enable individuals to take a nasal sample at home and send it to a laboratory for diagnostic testing, the second such approval it has made.
Dr. Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health, said in a statement that the new test “not only provides increased patient access to tests, but also protects others from potential exposure.” Health care workers can risk infection when they administer diagnostic tests.
The kit, made by Everlywell, will contain a swab for individuals to use to take a sample from inside the nostrils, and a tube filled with a saline solution to put it in for sending to one of two private lab companies: Fulgent Therapeutics or Assurance Scientific Laboratories. The company plans to partner with additional laboratories.
Some public health researchers have warned that at-home nasal swab tests can be less accurate than the specimen collection performed by health care providers, which involves inserting a long nasal swab through the nose into the back of the throat.
Christina Song, an Everlywell spokeswoman, said consumers will first take an online screening survey to determine whether they meet federal guidelines for the test. The survey will be reviewed quickly by health care providers affiliated with PWNHealth, the company’s telemedicine partner. If a consumer qualifies for the test, one will be shipped out immediately.
“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 designed to take three to five days,” Ms. Song said.
The test kits will be available later this month, according to Ms. Song, and will cost $135.
In announcing its authorization for the Everlywell testing kit, the F.D.A. said the company had “leveraged” data from studies supported by the Bill and Melinda Gates Foundation and UnitedHealth Group to show that the specimens would stay stable during shipping.
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.
Some of the company’s products, such as those purporting to test for food sensitivities, have come under criticism. Everlywell was also one of several businesses that drew attention from members of Congress in March for entering the market for coronavirus test kits in March without F.D.A. approval.
Everlywell, which had promoted its at-home kit as a consumer product, said in a statement at the time that it had not sold any of the kits to consumers, but was providing the test materials “at cost to hospitals and health care organizations who can commit to providing the test for free to their workers and patients.”
The F.D.A.’s announcement on Saturday follows other recent emergency use authorizations for coronavirus testing kits that also permit individuals to take samples at home. One, sold by LabCorp, also uses a nasal swab to collect a sample, which is then sent to the lab. 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. ​
