Dive Brief:

• LabCorp has received emergency use authorization for an at-home collection coronavirus test that is available without a prescription.

• The EUA marks the first time FDA has authorized an at-home COVID-19 collection kit for sale over the counter. LabCorp is selling the kit through its consumer-focused Pixel website and may expand into retail channels. 

• Patients who test positive or have an indeterminate result will receive a call from PWNHealth, an independent healthcare company that provides access to a nationwide telehealth physician network.

Dive Insight:

In April, LabCorp became the first company to receive an EUA for a COVID-19 diagnostic test with a home collection option. That kit, like at-home tests from other companies that subsequently came to market, was only available with a prescription. LabCorp has now become the first company to eliminate the need for a prescription. 

"While many home collection kits can be prescribed with a simple online questionnaire, this newly authorized direct-to-consumer collection kit removes that step from the process, allowing anyone to collect their sample and send it to the lab for processing," Jeff Shuren, director of FDA's Center for Devices and Radiological Health, said in a statement.

The agency is hoping the over-the-counter diagnostic will help more people get tested. The EUA summary states individuals will be asked screening questions when registering a kit bought at a retail location or making an online purchase. However, once the user has verified they are aged 18 years or older any answer will result in the distribution of the kit. The screening process will tell users that report severe symptoms to seek immediate care.

Effectively eliminating the screening step could lead to more use by people without symptoms. There have been reports of problems stemming from asymptomatic testing. Researchers have calculated a mass-screening program in the U.K. that used a lateral flow test generated as many false positives as true positives. At the University of Arizona, Quidel’s antigen test detected one-third of asymptomatic cases picked up by PCR.

As a PCR test, however, the available evidence suggests LabCorp's kit should perform better than the faster but less accurate diagnostics used in the U.K. and Arizona. LabCorp's EUA features data showing its kit was in 100% agreement with the results of the Roche Cobas SARS-CoV-2 Test when used to analyze 133 samples from asymptomatic individuals, including 20 positives.  

The asymptomatic data, like all the performance results quoted in the EUA, are identical to the figures LabCorp submitted for the prescription version of its at-home collection kit. The differences between the two EUAs are largely limited to explanations of the Pixel screening process and the role PWNHealth plays in informing patients of their results.

LabCorp's EUA comes weeks after FDA authorized the first fully at-home COVID-19 test. The Lucira Health molecular test kit, which requires a prescription, is designed to deliver results at home within 30 minutes but will only be available nationally from early spring onward.