At-home COVID-19 test gets 1st FDA authorization for over-counter sales

Chris Davies - Dec 10, 2020, 3:14pm CST
At-home COVID-19 test gets 1st FDA authorization for over-counter sales

The first direct-to-consumer COVID-19 testing system has been authorized by the US FDA, paving the way to easier and more widespread diagnostics that don’t require a doctor’s prescription. The hope is that the LabCorp test will soon be available over-the-counter, in addition to existing availability online.

COVID-19 testing has become a hot topic during the coronavirus pandemic, with demands for widespread diagnostics far outstripping availability. In addition to limited supplies – particularly earlier in the year, when CDC missteps added significant delays to the process – the majority of tests demand healthcare professionals take the samples.

There’s been a push, therefore, to develop test kits that can be used at home, with the samples then sent out to a lab for analysis. This week, the US Food and Drug Administration granted its first authorization for a direct-to-consumer, non-prescription test system. Based on a nasal swab, it’s available both with insurance, with recourse to federal test funding, or through direct payment.

LabCorp’s Pixel COVID-19 Test Home Collection Kit has been granted EUA (emergency use authorization). “This home sample collection kit can be purchased online or in a store without a prescription,” the FDA said of the decision. “It is intended to enable users to access information about their COVID-19 infection status that could aid with determining if self-isolation (quarantine) is appropriate and to assist with health care decisions after discussion with a health care professional.”

The kit includes a nasal swab system, the sample from which is then packaged up and sent to LabCorp for testing. That process takes 1-2 days, on average, the company says, from when it receives the sample; positive or invalid test results are delivered via a phone call from a healthcare provider. Negative results, meanwhile, are confirmed via email, or through LabCorp’s online portal.

LabCorp’s kit has been available online, though the company has been reserving supplies for those “experiencing symptoms or those who have been asked to get tested by a healthcare provider, public health department, or contact investigator.” Those ordering it have been able to bill their insurance or access public funding for the uninsured, or pay the $119 cost out of pocket.

With the EUA, however, LabCorp can now offer the kit through broader channels, including pharmacies and retailers. The kit itself remains the same.

Given the difficulty experienced by many of actually accessing COVID-19 tests, the CDC recently changed its guidelines on isolation following suspected exposure to the coronavirus. Those in quarantine can potentially cut their isolation after as little as 7 days, the CDC suggested, assuming a negative test result and no COVID-19 symptoms, or after 10 days without a test result.


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