LabCorp receives FDA approval to sell at-home coronavirus test

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LabCorp's COVID-19 in-home testing kit called Pixel

By Sarah Krueger & Rick Smith, WRALTechwire

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. Consumers will be able to buy the test only if recommended by a provider and after they have filled out a questionnaire.

“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,” LabCorp President and Chief Medical Officer Dr. Brian Caveney said. “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.”

“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.”

“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.

Tests for consumers are promised “in the coming weeks,” the company 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.”

This article originally appeared in WRALTechWire.

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

In announcing the forthcoming availability of a home COVID-19 test on Tuesday, LabCorp released a video and published a graphic to explain the test as well as how to administer it.

The following graphic explains how to get the test, administer it and submit the results:

For a larger version of this graphic, please visit this site.

This article originally appeared in WRALTechWire.

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