FDA allows first in-home test kit

The Food and Drug Administration on Tuesday said it had granted emergency clearance to the first in-home test for the coronavirus, a nasal swab kit that will be sold by LabCorp.

The agency said that LabCorp had submitted data showing the home test is as safe and accurate as a sample collection at a doctor’s office, hospital or other testing site.

“With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” Dr. Stephen M. Hahn, the FDA commissioner, said in a statement.

Patients will swab their own nose using a testing kit sent by the company and will mail it in an insulated package back to the company. The Pixel by LabCorp COVID-19 test will be available to consumers in most states, with a doctor’s order, the agency said.

LabCorp said that it would first make the tests available to health care workers and emergency workers who may have been exposed to COVID-19 or be symptomatic, and that it would be making the self-collection kits available to consumers “in the coming weeks.” The company also noted that because the tests are done by consumers in their own home, it would cut down on the demand for masks and other protective equipment that is usually needed to collect testing specimens.

The company said the test will cost $119. Consumers will have to pay out of pocket for the test, a company spokesman said, and ask their insurer for reimbursement. The Trump administration has repeatedly said that diagnostic tests for the coronavirus will be covered so that consumers don’t have to foot the bill.

At a moment when governors across the country say their states are facing a shortage of tests, and companies like CVS and Walmart are setting up drivethrough testing centers in parking lots, the arrival of kits that let people collect their own nasal specimens at home has the potential to open up testing to a wider audience.

Medical experts said the home-swabbing tests could increase convenience for consumers — and reduce the need for people to go to medical offices where they might inadvertently expose health providers and other patients to the infection.