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First COVID-19 Test with At-Home Sample Collection Approved

The first at-home collection kit has been approved...but there's a catch.

The first COVID-19 test with an at-home collection option was approved
The decision only applies to LabCorp's Pixel test
Accuracy and safety were the primary reasons for the decision
Capitol Building

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.

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1 FDA