FDA Grants EUA for LabCorp ’s At-Home COVID-19 Test

FDA has granted emergency use authorization LabCorp’s Pixel, an at-home test for the novel coronavirus (COVID-19). In a Tuesday release, the federal agency said this is the authorization of the first diagnostic test with a home collection option for COVID-19. The Burlington, NC-based company’s Pixel permits testing of a sample collected from the patient’s nose using a designated self-collection kit that contains nasal swabs and saline. Once patients self-swab to collect their nasal sample, they mail their sample, in an insulated package, to a LabCorp lab for testing. LabCorp pointed out the test hasn’t been FDA cleared or approved and that the EUA is only for the detection of nucleic acid from SARS-CoV-2, not any other viruses or pathogens. In a release, FDA Commissioner Stephen Hahn, MD, said, “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 sites. With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home.â&#...
Source: MDDI - Category: Medical Devices Authors: Tags: IVD Regulatory and Compliance Source Type: news