Coronavirus (COVID-19) Update: FDA, Gates Foundation, UnitedHealth Group, Quantigen, and U.S. Cotton Collaborate to Address Testing Supply Needs

FDA News Release

• For Immediate Release: April 16, 2020

The U.S. Food and Drug Administration announced a further expansion of COVID-19 testing options through the recognition that spun synthetic swabs – with a design similar to Q-tips – could be used to test patients by collecting a sample from the front of the nose.

As part of this effort, U.S. Cotton, the largest manufacturer of cotton swabs and a subsidiary of Parkdale-Mills, developed a polyester-based Q-tip-type swab that is fully synthetic for compatibility with COVID-19 testing. Harnessing its large-scale U.S.-based manufacturing capabilities, U.S. Cotton plans to produce these new polyester swabs in large quantities to help meet the needs for coronavirus diagnostic testing.

“This action today demonstrates the ingenuity that results from the FDA working in partnership with the private sector. The Trump Administration has been working side-by-side with our industry partners to fight this pandemic, and today is a great example of that work. We appreciate work by UnitedHealth Group, Quantigen, and the Gates Foundation to perform and support the clinical studies necessary for this advancement. We also want to acknowledge U.S. Cotton’s efforts to manufacture a new type of swab for COVID-19 testing that can be produced at scale. We appreciate the work of these collaborators to consider how these test supplies could be broadly distributed to meet not only the testing needs of the United States but also global needs around the pandemic. All of these actions by these American organizations will help continue to expand our testing capability,” said FDA Commissioner Stephen M. Hahn, M.D.

This finding that spun synthetic swabs could be used for COVID-19 testing is based on results from a clinical investigation that represents a collaboration between the FDA, UnitedHealth Group, the Gates Foundation, and Quantigen. The type of testing at the front of the nose used in this study is notable because it allows self-collection by patients thereby limiting exposure of healthcare providers; it is more comfortable for patients and it can be performed by a swab that is more readily available and manufacturable at scale.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.