The debate over whether or not the United States is ready to reopen or not really comes down to one thing: testing. Are we testing enough people every day to make sure that the virus is at a point where we can know who is and is not infected, so we can isolate those people from the rest of the population? Right now, the answer seem to be a resounding, "no, we are not testing nearly enough people" for it to be safe.
We might be getting closer, though, now that LabCorp announced on Tuesday that it has received an Emergency Use Authorization (EUA) from the FDA to allow for in-home testing. The test kits will first being distributed to healthcare workers and first responders who may have been exposed to COVID-19 or who may be symptomatic. The company intends to make the kits available to all consumers around the country in the coming weeks.
The kits will be offered through the company’s Pixel by LabCorp platform, its consumer-facing wellness test offering that it introduced in 2018.
“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,” Adam Schechter, president and CEO of LabCorp, said in a statement. “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time.”
According to a press announcement from the FDA, the LabCorp home self-collection kit "includes a specific Q-tip-style cotton swab for patients to use to collect their sample," and the agency says other cotton swabs should not be used "due to concerns with sterility and cross-reactivity."
LapCorp made sure to note that its COVID-19 test home collection kit has been "authorized under an EUA" by the FDA, but not yet either "cleared" or "approved" by the agency. VatorNews has reached out to LabCorp for more clarification on the difference between authorization and approval, and what that means for the availability of the kit. We will update this story if we learn more.
“Throughout this pandemic we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options,” FDA Commissioner Stephen M. Hahn said in a statement.
“The FDA’s around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers. Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.”
(Image source: pixel.labcorp.com)
