FDA approves first at-home coronavirus test

April 21, 2020

The Food and Drug Administration announced Tuesday that it has approved the first authorized at-home coronavirus test. The test will be made available first to health care workers and first responders, and is expected to go on sale for consumers in most states within weeks.

The test, called Pixel, is a nasal swab kit developed and sold by LabCorp. Patients will collect their own samples using a special sterile swab provided in the kit and then send it in to one of the company’s labs for analysis.

The FDA said it granted the company emergency approval to get the tests out sooner.

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

We received approval from @US_FDA to perform #COVID19 tests using an at-home collection kit. These kits reduce the need of #PPE used by healthcare workers. Initially, kits will be made available to frontline healthcare workers and first responders. https://t.co/X4XQmHDxRN pic.twitter.com/vKsKucclif

— LabCorp (@LabCorp) April 21, 2020

The test kit costs $119, and potential customers must complete a survey about their eligibility for testing before receiving one. LabCorp spokesman Mike Geller told CBS News that customers must pay up front for the test and “should contact their insurer to determine if their plan would reimburse them for expenses.”

The test’s website says it will not be available in New York, New Jersey, Maryland and Rhode Island. Those states are excluded because they have regulations against patients initiating their own lab tests, Geller said. New York and New Jersey are the two states with the highest number of coronavirus cases and deaths.

LabCorp said the tests will initially be available to frontline workers who may have been exposed to COVID-19 or may be symptomatic, and then the tests will go on sale for the public “in the coming weeks.”

Health officials have warned consumers in the past to avoid any non-approved home tests they may have seen promoted on social media, and the FDA repeated that warning in its statement Monday.

“It is important to note that this is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home,” the FDA said.