LabCorp Granted Authorization for COVID-19 Test Home Collection Kit

Burlington-based LabCorp has received Emergency Use Authorization from the U.S. Food and Drug Administration to sell its COVID-19 test home collection kit, the first to be available over the counter without requiring a prescription.

The kit, marketed as Pixel by LabCorp, is currently available through the Pixel by LabCorp website, and the FDA authorization will enable the company to potentially distribute the kit through retail channels, according to a company news release

The kit, shipped via FedEx, allows consumers to self-collect their test sample with a cotton nasal swab in the privacy of their home, helping reduce transmission of the virus. Users then send the sample for processing at LabCorp, which tests it for the presence of SARS-CoV-2, the virus that causes COVID-19

“With the first over-the-counter at-home collection kit ever authorized by the FDA for COVID-19, we are empowering people to learn about their health and make confident decisions,” said Brian Caveney, M.D., chief medical officer and president of LabCorp Diagnostics. “With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.

Upon purchase, users register their collection kit at the Pixel by LabCorp website and follow the instructions included with the kit. Test results are securely delivered to the consumer via the Pixel by LabCorp portal.

The average time to deliver results is currently 1-2 days from when the sample is received at the lab. The company processes samples seven days a week

A healthcare provider will counsel consumers who test positive to assist with healthcare treatment and actions. The company cautions that the kit is not a substitute for visits to a healthcare professional and is for use in adults 18 and older

The test does not detect antibodies or immunity to COVID-19. It is a molecular test designed to determine active infection with the virus that causes COVID-19

Samples are analyzed using the company’s proprietary RT-PCR (reverse transcriptase polymerase chain reaction) technique, considered to be the gold standard for diagnosing active COVID-19 infections. LabCorp’s PCR test has not been FDA cleared or approved but has been authorized under an Emergency Use Authorization

Due to the surge in COVID-19 cases, home collection kits are currently reserved for people who are experiencing symptoms, have been exposed to someone with COVID-19, or who have been recommended for testing by a healthcare provider, public health department, or contact investigator, according to the company’s website.

Retailers interested in selling Pixel by LabCorp COVID-19 collection kits can contact the company at PixelPartners@LabCorp.com.

LabCorp is a global life sciences company that provides clinical laboratory and drug development services. It reported revenue of more than $11.5 billion in 2019.

An S&P 500 company, LabCorp employs about 61,000 people worldwide, including 7,300 people across North Carolina.