If you have recently thought about getting tested for COVID-19 and Googled how to do it, you’ve probably seen advertisements of “physician-approved” at-home test kits made by startups here and there. But none of them have been actually approved by the Food and Drug Administration, until now.
On Tuesday, the FDA said it had granted the first emergency approval regarding self-administered COVID-19 tests—to a kit made by LabCorp, a health diagnostics company based in Burlington, N.C., that would allow patients to collect coronavirus samples using a Q tip at home without the risk of spreading or contracting the virus in a traditional test setting.
“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics…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 M. Hahn said in a statement on Tuesday.
The test kit, called Pixel, will be sold in most states for $119 each with a doctor’s order. LabCorp said it would make the tests available to frontline health care workers first and roll out to consumers “in the coming weeks.”
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 Pixel kit works similarly to self-administered DNA tests made by companies like 23andMe. Patients will be asked to swab their noses using the kit and then mail it in an insulated package back to the company. Results will be available online in a few days.
Consumers will have to pay out of pocket for the test and then ask their insurer for reimbursement, LabCorp said. Congress signed legislation last month requiring that 100 percent of COVID-19 test costs be covered by private insurers or public programs.
The FDA said that data from LabCorp has shown that its home tests are just as safe and accurate as tests conducted at a doctor’s office or hospital. And yet, some researchers have found that nasal swabs tend to a higher false negative rate than the longer swabs used by professional health care workers.
Since the coronavirus outbreak, the FDA has reviewed over 350 novel diagnostic kits and approved more than 50.