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

The Burlington, NC-based company’s test would initially be available for healthcare workers and first responders who could have been exposed to COVID-19 or might be symptomatic. In the coming weeks, LabCorp said it plans to make the at-home test available to the public.

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.”

The company said it intends to make the Pixel platform available to healthcare workers and first responders who might have been exposed to COVID-19 or could be symptomatic. In the next few weeks, LabCorp said it would make the test available for the public.

The EUA of Pixel comes at a time when there is public outcry for more widespread testing. Diagnostic companies are stepping up to the plate and are either working on or offering assays that can get results back quickly.

On Monday, FemtoDx revealed its plan to develop a rapid at-home test for COVID-19. The Beverly Hills, CA-based diagnostics firm said the test results could be available in less than five minutes.

Abbott Laboratories has also developed a five-minute COVID-19 test, but it isn’t for at-home use. For more of MD+DI's ongoing coverage of resources, regulatory support, and solutions for responding to the COVID-19 pandemic, visit our COVID-19 News Central page.

 

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