The Food and Drug Administration said it has granted the first diagnostic home test for COVID-19, re-issuing emergency approval for a nasal swab kit that can be done at home by patients.
The test – which will be sold by LabCorp – can only be done with a doctor’s order. LabCorp’s “Pixel” will be available to patients in most states in the coming weeks, according to the FDA.
“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.”
Patients who receive the test will receive a self-collection kit that contains nasal swabs and saline, according to the FDA. Once patients self-swab their nasal sample, they will mail it to a LabCorp lab for testing.
LabCorp said that it plans to make the tests available to health care workers and first responders who have symptoms consisted with COVID-19.
“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,” LabCorp CEO Adam Schechter 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.”
The New York Times reported the test will cost $119, which will come out of pocket, citing a LabCorp spokesman.