LabCorp receives FDA approval to sell at-home coronavirus test

BURLINGTON – Health diagnostics giant LabCorp will begin selling an at-home test for the COVID-19 virus after receiving emergency authorization from the U.S. Food and Drug Administration.

Called Pixel, the test will cost $119 and will include collection of specimens via nasal swabs.

The test is being marketed first to health care providers and first responders and isn’t yet available to the general public. Company officials said they expect to expand the availability of the test kits in the coming weeks if adequate supplies are available.

FDA Commissioner Stephen Hahn said in a statement that the FDA authorized the self-swab test based on data showing it is “as safe and accurate as sample collection at a doctor’s office, hospital or other testing site.”

Consumers must fill out a health questionnaire before they can obtain a kit.

“The person fills out some information on there, and then we ship the box to their home, give them instructions on how exactly to collect the specimen for themselves,” said Dr. Brian Caveney, president and chief medical officer of LabCorp Diagnostics. “They put it into a special package and get it to a FedEx dropbox that day so that we can very quickly get it back to our lab here in North Carolina, process the specimen and then get them the results as quickly as possible.”

Here’s how to use at-home COVID-19 test from LabCorp

“Once we get it into the lab, it’s a matter of hours to process the sample and then return the results,” Caveney said. “The whole process, start to finish, will typically be a couple of days.”

The Durham Police Department hasn’t explored testing for its officers, spokeswoman Kammie Michael said.

“The health and well-being of our officers is a priority during this coronavirus pandemic, and we will continue to evaluate all proactive measures to protect our employees throughout this evolving crisis,” Michael said in an email.

Self-tests will help conserve face masks, gloves, gowns and other personal protective equipment that is currently in short supply nationwide, Caveney said.

“If a person collects it on themselves, of course, a health care worker doesn’t need to use those extra pieces of equipment to collect the specimen,” he said.

“It would certainly be nice if someone in my family had the symptoms to be able to see that at home,” Durham resident Chris Carmody said. “Frankly, we are trying to avoid the hospital and even the doctor’s office, too. So, from that perspective, it would be nice.”

“[I’m] a little leery because there’s so much that’s not known about the test. So, the accuracy would be something that I would factor in,” Durham resident Harriett Ware said.

Caveney said LabCorp worked with the FDA to design the test so that it’s easy to use.

“We worked very closely with the FDA to validate every step in the process and make sure that it is just as good as the processes, as a specimen collected in your doctor’s office,” he said. “We put instructions in the box to make it very clear what to do.”

LabCorp has been ramping up efforts over the past several weeks to deal with the pandemic after rolling out its own test in early March.

“We have been getting inbound inquiries from as soon as the press release went out,” Caveney said, noting LabCorp has 60,000 tests available.

“We hope, as our capacity increases, we hope to be able to expand to other priority populations as soon as we can,” he said.

Other firms, according to medical news site GoodRX, offering at-home tests include:

Everlywell
Nurx
Carbon Health
Scanwell Health

LabCorp noted that the FDA’s emergency use authorization doesn’t mean the test has been approved. It “has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens,” the company said in a statement.

“The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19.”