- For Immediate Release:
The following quote is attributed to Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health
Today, the U.S. Food and Drug Administration took steps to further facilitate the authorization of molecular tests for screening asymptomatic individuals using pooled anterior nasal respiratory specimens in serial testing programs. The FDA issued an amendment for many molecular diagnostic COVID-19 tests that had received an emergency use authorization (EUA). If a test developer has self-certified it has validated its test for pooling, FDA will add that test to a list of tests that can be used for pooling nasal specimens as part of a serial testing program. Pooling, the process of combining multiple specimens together to more quickly test groups of people for SARS-CoV-2, can be an efficient approach for a serial testing program that tests many people on a routine basis. The flexibility that the FDA has provided developers continues to be a hallmark of our approach to the COVID-19 pandemic and we will continue to prioritize authorization for tests with the ability to increase testing accessibility or to significantly increase testing capacity. The FDA is committed to assisting our schools, workplaces, communities and other entities with establishing effective testing programs as the national response to the COVID-19 pandemic continues to evolve.
- Today, the FDA authorized an amendment for many molecular diagnostic SARS-CoV-2 tests authorized for diagnosis or screening, which allows emergency use of such tests on pooled specimens for testing individuals without symptoms or other reasons to suspect COVID-19, when tested at least once per week as part of a serial testing program without prospective FDA review. The amendment applies only to pooling of anterior nasal respiratory specimens.
- To utilize this approach, EUA holders must submit a notification to FDA with specific required information, including validation data (if requesting to pool more than three specimens) and pooling procedures.
- After this notification is given, the test will be identified on the FDA website and updated labeling will be posted with the test’s EUA on the FDA website.
- The public, including organizations purchasing tests to use for testing pooled specimens in serial testing programs, will be able to see the full list of tests authorized for any additional indication under this amendment on the FDA website as well as search the main EUA list on the FDA website to quickly find tests authorized for “pooled serial screening” which will be added as an attribute for each test amended by this authorization.
- Last month, the FDA issued a new supplemental template for test developers seeking emergency use authorization of certain tests for screening with serial testing. This Pooling and Serial Testing Amendment builds upon that earlier action.
- All serial testing programs should include retesting individuals as needed. Additionally, testing does not replace the need for other public health measures such as getting vaccinated, social distancing, washing hands and wearing masks.
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.
- Audra Harrison