Every step we have taken as part of our approach to COVID-19 testing has been a careful balancing of risks and benefits in order to meet the urgent public health needs as we combat this new pathogen. We have moved quickly and thoughtfully, and we are continuing to learn and adapt based on the real-world experience and data we’re seeing. In the meantime, frontline health care workers who are making life-and-death decisions every day in their fight against this novel coronavirus need to have all the information possible to make educated decisions about which test to use to help identify individuals who have developed an immune response to the virus. We are committed to providing as up-to-date information as possible to support their heroic efforts.
As the country starts to see positive signs that the mitigation efforts, like stay-at-home orders and social distancing, are working in our fight against the COVID-19 pandemic, the question of when we can return to work and resume our normal activities is one of the most critical issues facing our nation. Antibody tests – also known as serological tests – may have the potential to play a role in this complex calculation. Results from these tests can help identify who has been infected and developed antibodies that may protect from future infection as well as identify those still at risk. Results can also help inform who may qualify to donate blood that can be used to manufacture convalescent plasma, an investigational product for use with those who are seriously ill from COVID-19.
Today, given the active dialogue about serological tests that are currently on the market, and their significance in the nation’s response efforts, we’d like to provide further details about our thinking on these tests and our approach to making accurate and reliable serology tests widely available, while also protecting Americans from tests marketed with false or unsubstantiated claims.
FDA Approach to Expanding Access to Serology Tests
First, we continue to provide the opportunity for interested developers to request FDA authorization through the emergency use authorization (EUA) process. To date, we have already issued four EUAs for serological tests, and we expect that number to continue to grow in the coming weeks. The FDA encourages developers to submit EUA requests for their tests, as an EUA will provide laboratories and providers with assurance that FDA has reviewed that test. We are working around-the-clock to review EUA submissions quickly and we continue to take steps to ensure the process is as streamlined and efficient as possible. For example, we are working on EUA Templates that laboratories and commercial manufacturers may use to facilitate the preparation and submission of an EUA request. We expect to make them available in the coming days.
To enhance the U.S. Government’s ability to identify well-performing tests and inform FDA recommendations and decision making, we are collaborating with the National Institutes of Health’s National Cancer Institute (NCI) and National Institute of Allergy and Infectious Diseases (NIAID) and the Centers for Disease Control and Prevention (CDC) to establish a capability at NIH to evaluate serological tests for developers. This effort includes tests already available for use, as well as tests not yet on the market where additional validation data is needed to support an EUA. Performance assessments for serological tests will begin soon, and we expect to start seeing results shortly thereafter. We will review NIH’s results expeditiously, and performance results from NIH’s assessment may complement and inform the determination of whether FDA issues an EUA for a particular test.
Recognizing that more flexibility was needed during a pandemic of this scale and speed, and incorporating feedback from the medical community, states and test developers, we have also provided regulatory flexibility for serological tests in an effort to provide laboratories and health care providers with early access to these tests with the understanding that the FDA had not reviewed or authorized (or "approved") them, at least not initially, and these tests should not be used for diagnosing or excluding active SARS-CoV-2 infection. Specifically, last month, as part of our broader strategy, the FDA issued a policy explaining that FDA does not int...
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