This morning, the FDA announced that they approved the first COVID-19 test with an at-home collection option.
This move reverses the clarification that the FDA’s March 23 Emergency Use Authorization (EUA) did not apply to at-home-collection, a decision that caused confusion in the pharmaceutical industry.
According to FDA Commissioner Stephen M. Hahn:
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 options1
However, there’s a catch – the approval only applies to one company, LabCorp. Utilizing their Pixel home collection kit, the test collects a nasal sample.
This leaves other early responders like Carbon Health and Nurx still unable to distribute the at-home tests they had planned in response to the original EUA.
According to Hahn, the FDA worked in tandem with LabCorp to:
- Ensure the safety of tests
- Ensure that the Pixel home test was as accurate as one conducted in a clinical setting
For more information, read the official release here.