The FDA is warning consumers against unauthorized COVID-19 test kits marketed for use in the home.
The agency said it has not authorized any diagnostic test for the virus for at-home use, nor has it endorsed any prevention or treatment claims that individual companies have made. The FDA also said it is not naming any companies it suspects of making fraudulent claims about their COVID-19 diagnostic tests.
Last week, a few organizations reported the availability of tests for sale while they await FDA authorization. On Friday, the agency put the kibosh on efforts by Austin, Texas-based Everlywell to market its at-home COVID-19 tests.
Everlywell said Tuesday that the company was working with fewer than 10 CLIA-certified labs to fast-track development of at-home tests and that all of those laboratories were working under FDA emergency use authorization guidelines.
After announcing last Wednesday that it has 30,000 tests ready to ship, the home-testing company learned on Friday that the FDA would not allow it to sell the COVID-19 tests for home use. An Everlywell spokesperson said the company is working directly with the FDA to understand what the agency wants and is seeking any potential new guidance around at-home collection for COVID-19 testing.
“For the time being, Everlywell’s COVID-19 test will only be available to qualifying hospitals and healthcare companies who can commit to providing the test for free to healthcare workers and high-risk, symptomatic patients affected by the testing shortage,” the company said in an online statement. “The test will be administered by healthcare providers.”
In its own news release, the FDA said it “sees the public health value in expanding the availability of COVID-19 testing through safe and accurate tests that may include home collection, and we are actively working with test developers in this space.”
San Francisco telemedicine provider Nurx was ready to launch its own at-home COVID-19 test as well, but decided to delay the move. Nurx spokesperson Allison Hoffman said the lab that developed the test, Molecular Testing Labs, had conducted its validation in accordance with FDA emergency use authorization guidance issued on Feb. 29.
On March 21, the FDA issued a “Frequently Asked Question” response that directly addressed at-home, self-collection of specimens for laboratory testing for COVID-19, stating that its earlier guidance does not apply to such testing. Given the March 21 guidance, “Nurx and Molecular have made the responsible decision to pause on providing any additional self-collection COVID-19 tests,” Hoffman said. “Molecular is in direct communication with the FDA regarding this most recent guidance and they continue to have high confidence in the test characteristics and accuracy of its self-collection COVID-19 test.”
On March 10, the agency announced it and the Federal Trade Commission had jointly sent warning letters to seven companies ordering them to stop selling fraudulent COVID-19 products, including teas, essential oils, tinctures and colloidal silver.
“Fraudulent health claims, tests, and products can pose serious health risks,” the FDA said in a March 20 statement. “They may keep some patients from seeking care or delay necessary medical treatment.”
The agency said it expects to issue more warning letters and may also resort to seizures or injunctions to stop the sale of fraudulent cures and treatments for COVID-19.
“Additionally, we are stepping up enforcement at ports of entry, including international mail facilities, to ensure these fraudulent products that originate outside the country do not enter through our borders,” the agency added. “If you are aware of fraudulent test kits for COVID-19, please report them to the FDA. We will continue to aggressively pursue those who place the public health at risk and hold bad actors accountable.”