LabCorp receives FDA approval to sell at-home COVID-19 test

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

Called Pixel, the test will cost $119.

The test will include a collection of specimens via nasal swabs.

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

Here’s how the test procedure works:

1. Complete a short eligibility survey

2. If you’re eligible*, purchase your kit

*Test requests are evaluated and, if appropriate, authorized by an independent physician.

3. Receive your sample collection kit via FedEx

4. Collect your sample and send it back to our world-class lab for testing

5. Access your results online

More testing of people for COVID-19 has been cited as a requirement for the speeding up of a reopening for the US economy.

Your test results will confirm whether or not you are infected with SARS-CoV-2. If your results are positive, it is important to limit your exposure to other people and continue to monitor your symptoms. If your results are negative, the virus was not present in the sample you provided. However, it is important to note that the virus may not be detected by the test in early stages of infection. Furthermore, the virus may not be detected if the sample is not collected as directed. If you have reason to believe you have been exposed, it is important to follow up with a healthcare provider for further evaluation or to get re-tested.

After receiving your results, you will have the opportunity to speak with a licensed physician who can answer any questions you may have about your test results and help determine next steps in care.

Source: LabCorp

FDA approval came through an emergency use authorization.

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.

“Enabling individuals to self-administer sample collection will help prevent the risk of transmitting the virus to others and reduces the demand for personal protective equipment (PPE) as the tests do not require a clinician to perform the test collection,” LabCorp explained in the announcement made early Tuesday.

The first kits will go to healthcare workers and first responders who have been exposed to the virus or may be symptomatic, the Burlington-based company said.

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

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

  • Everlywell
  • Nurx
  • Carbon Health
  • Scanwell Health

“LabCorp continues to develop new ways to help patients and healthcare providers fight the COVID-19 crisis through our leading testing capabilities and deep scientific and research expertise,” said Adam Schechter, CEO of LabCorp. “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time.”

However, LabCorp noted that the emergency use authorization did not mean the test has been FDA cleared or 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.

“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.”

Original Article Source: WRAL TechWire