FDA clears another coronavirus testing kit for use at home

Everlywell is the second company to be granted FDA's emergency clearance for an at-home coronavirus testing kit. FDA says the company "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 is the second company to be granted FDA's emergency clearance for an at-home coronavirus testing kit. FDA says the company "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. Jeffrey Shuren, MD, director of FDA's Center for Devices and Radiological Health, says the new test "not only provides increased patient access to tests, but also protects others from potential exposure." Health care workers can risk COVID-19 infection when they administer diagnostic tests. Everlywell's kit will contain a swab for taking a sample from inside a person's nostrils, and a tube filled with a saline solution to put the swab in for sending to one of two private lab companies, Fulgent Therapeutics or Assurance Scientific Laboratories. The company intends to work with additional laboratories. Some public health researchers say at-home nasal swab tests can be less accurate compared with those that require a long nasal swab to be inserted through the nose to the back of the throat. Everlywell spokeswoman Christina Song says consumers will be required to take an online screening survey to determine if they fulfill federal guidelines for the test. The survey will be assessed by health care providers affiliated with PWNHealth, a telemedicine firm, and if a consumer qualifies, a test will be shipped out immediately. Song says the entire "process is designed to take 3 to 5 days," at a cost of $135. The test kits are expected to be available later in May, she says.