BURLINGTON, N.C.– Labcorp (NYSE: LH), a leading global life sciences company, today announced the receipt of Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for a combined at-home collection kit available that simultaneously detects COVID-19, influenza A/B and respiratory syncytial virus (RSV), a common but contagious respiratory virus often seen in children.
The Pixel by Labcorp COVID-19+Flu+RSV Test Home Collection Kit will be available for use by individuals age 2 and older through the Labcorp OnDemand™ digital health platform without a prescription. For those who meet clinical guidelines and have insurance, the kit is available at no upfront cost. By using the Labcorp kit to determine whether they have contracted COVID-19, flu or RSV, individuals are choosing the reliability of PCR testing—considered the gold standard for diagnosing COVID-19 and its variants—to make key health decisions.
“Labcorp’s COVID-19 tests have been trusted by physicians and millions of people throughout the pandemic. This new at-home collection kit makes it easier for consumers to access testing for multiple respiratory viruses – COVID-19, the flu and RSV – that can present similar symptoms,” said Dr. Brian Caveney, chief medical officer and president of Labcorp Diagnostics. “With the spike in RSV cases over the last year, the continued presence of COVID-19, and the ever-present threat of flu, testing for all three viruses at once enables individuals and physicians to quickly identify the illness and determine the appropriate treatment.”
The Pixel by Labcorp COVID-19+Flu+RSV Test Home Collection Kit is shipped via FedEx Priority Overnight to an individual’s home. Once collected, the sample is returned to Labcorp via a prepaid return envelope. Test results are available through an individual’s Labcorp OnDemand account 1-2 days on average after Labcorp receives the completed collection kit.
If a person tests positive, they will receive a call from a third-party physician network with detailed next steps and access to a free clinician consult. Clinical guidelines for receiving the kit at no upfront cost with insurance include experiencing symptoms, being exposed to someone with COVID-19, or receiving a request to get tested from a health care provider. This test is only intended for individuals experiencing flu-like symptoms.
The new at-home test collection kit is the latest example of Labcorp’s commitment to delivering innovations that help physicians, health systems and consumers respond to the pandemic. Labcorp, a leader in COVID-19 testing with more than 74 million tests performed, continues to be a key contributor to the pandemic response. The company is consistently working to expand COVID-19 testing access and further the development of COVID-19 vaccines and therapies.
Labcorp’s combined home collection kit for COVID-19, influenza A/B and RSV has not been FDA cleared or approved and has been authorized by the FDA under an emergency use authorization only for the detection of nucleic acid from SARS-CoV-2, influenza A and/or influenza B, and RSV, not for any other viruses or pathogens. 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 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
