FDA authorizes first at-home COVID-19 test
On April 21, 2020, the Food and Drug Administration (FDA) announced its approval of the first at-home COVID-19 test pursuant to its Emergency Use Authorization (EUA) authority.
The FDA noted that this EUA applies only to the LabCorp COVID-19 Pixel kit for at-home testing of COVID-19, which requires a doctor’s order. To perform the test, a nasal swab specimen must be collected using a specific Q-tip-style cotton swab. The FDA stated, "It is important to note that this is not a general authorization for at-home collection of patient samples using other collection swabs, media, or tests, or for tests fully conducted at home."
Once patients collect their own samples by doing the nasal swab from the Pixel test kit, they will mail the specimen to a lab for testing. The upfront pricing of the test is $119, as shown on the company's website. While this test would presumably be covered by insurance as required by the Coronavirus Aid Relief and Economic Security (CARES) Act, it is unclear if it will be met with pushback from insurers due to medical necessity considerations; the fact that it is self-performed and not in the presence of medical professionals. This test kit is expected to become widely available to consumers in most states in the next several weeks, but will not be available in Maryland, New York, New Jersey or Rhode Island.
According to the FDA authorization letter sent to LabCorp, “There is no adequate, approved, and available alternative to the emergency use of LabCorp’s COVID-19 Test for diagnosing COVID-19,” although the FDA press release remarks that the data from the at-home sample collection is as safe and accurate as sample collection at a doctor’s office, hospital or other testing site.
Consumers should note that a test receiving EUA status is not the same as a test receiving “FDA approval.” Tests may be authorized for public use through an FDA Emergency Use Authorization under § 564 of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which explains that the FDA Commissioner may “allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions when there are no adequate, approved, and available alternatives.”
Under normal circumstances, FDA approval is generally only given to medical tests or treatments following several phases of adequate investigation and review of substantial evidence to determine that tests or treatments are in fact safe and effective for their intended use and that benefits outweigh the risks of the intended use. Until another alternative or an approved version becomes available for at-home testing of COVID-19, this LabCorp test will likely remain in high demand.
McDonald Hopkins continues to monitor the FDA’s guidance on authorized and approved COVID-19 testing and will issue alerts on additional testing options as they become available to the public.
For additional information please contact the attorneys below.
