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FDA Authorizes At-Home COVID-19 Test as Demand for Tests Heats Up

April 21, 2020
More than 50 diagnostic tests have received emergency use authorizations as officials stress the importance of ubiquitous testing

On April 21, the Food and Drug Administration gave the Laboratory Corporation of America’s COVID-19 RT-PCR test an emergency use authorization. LabCorp’s test allows patients to collect their own samples at home. According to the FDA, the government body has issued more than 50 such authorizations for tests of the virus.

The procedure for the test involves a saline solution and a nasal swab. Patients collect a sample using the nasal swab and mail it to a LabCorp lab for it to be tested remotely. According to the FDA, LabCorb’s tests will be available in most states if consumers get a doctor’s order.

The FDA’s statement also included a note that the authorization does not authorize the at-home collection of samples using any other means than LabCorp’s swab, since other swabs might not be effective with existing tests. “We worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate” as samples taken at a doctor’s office, said FDA Commissioner Dr. Stephen Hahn. “With this action, there is now a convenient and reliable option for patient sample collection from the comfort and safety of their home,” said Hahn.

According to LabCorp CEO Adam Schechter, the at-home kits should increase availability of tests while reducing the risk of transmitting the virus. Additionally, since the tests are self-administered, they require less personal protective equipment to be used compared to other tests, which are administered by clinicians. “Our at-home collection kits are designed to make it easier and safer to test healthcare workers and first responders during this important time,” said Schechter in a statement.

The tests will be offered through LabCorp’s “Pixel” platform, where they’re currently listed for $119, but they’re not available to the general population yet.  A statement from LabCorp notes the tests are initially only available for medical workers and first responders. Another potential hurdle for the tests: LabCorp’s online platform for ordering tests is unavailable in New York, New Jersey, Maryland or Rhode Island due to state restrictions on ordering lab tests there.

The large number of emergency authorizations for coronavirus tests shows the urgency many government officials feel on ramping up testing for the virus. The White House, after issuing guidelines for governors to use while reopening their states, has publicly parred with governors about the availability of enough tests to accurately gauge how much of the virus remains in the population.

While the White House insists that the number of tests available is adequate, governors from both parties have disputed that. Larry Hogan, the Republican governor of Maryland, drew a rebuke from President Trump after news broke that Hogan’s wife had negotiated the delivery of half a million test kits from South Korea. The governor of New York, Andrew Cuomo, today called for the federal government to coordinate interstate supply chains for the tests.

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