May 21, 2020 -- The American Association for Clinical Chemistry (AACC) has notified the U.S. Food and Drug Administration (FDA) that it objects to the agency's recent emergency use authorization (EUA) of an "unproven" at-home coronavirus collection kit.
The FDA has been approving products related to SARS-CoV-2 rapidly through the EUA pathway. In a letter to FDA Commissioner Stephen Hahn, the AACC said that this haste has resulted in the "introduction of an unproven product into the market." The letter referenced a product that received clearance on May 16, without noting a product or company name.
The FDA granted emergency authorization to Everlywell's at-home nasal sample collection kit for COVID-19 testing on May 15, noting at the time that this is the only product of its kind authorized for use with multiple COVID-19 diagnostic tests.
In the letter to the FDA, President Carmen Wiley, PhD, said there is insufficient information about the quality of the product in the EUA.
"A review of the FDA's EUA to this company does not indicate that adequate clinical studies were performed to validate the kit or that good manufacturing practices were followed to develop it," she wrote. "Further, the company selling the kit is not a laboratory."
Increasing access to home-use collection kits can expand testing capacity and meet the need for fast diagnoses, but inaccurate results can do more harm than good, she wrote, urging the FDA to improve transparency in its regulatory decisions.
"We urge the FDA to withdraw its approval of this EUA or release the underlying clinical information that served as the basis for its expedited review," Wiley wrote. "Authorization for this test kit should not be granted until the FDA has received and assessed the missing information and has released these data to the public."