COVID-19 Update: Serological Test Efforts

The following is a summary comments attributed to Commissioner of Food and Drugs - Food and Drug Administration, Stephen M. Hahn, M.D.

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. Frontline health care workers 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.

Antibody tests – also known as serological 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.

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 grow in the coming weeks.

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.

Recognizing that more flexibility was needed during a pandemic, 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, 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 intend to object when developers of serological tests market or use their tests without prior FDA review where: 1) the tests are validated by the developer to determine that they are accurate and reliable, 2) notification of the developer's validation is provided to FDA, and 3) the tests are labeled appropriately, including that they are not to be used as a sole basis for diagnosis. The policy does not apply to at-home specimen collection or at-home testing. The policy does apply to tests that can be performed in patient care settings. Laboratories could validate tests they receive from commercial manufacturers and determine if they should be used in their facilities.

Unlike a test designed to diagnose an active COVID-19 infection, serological tests can help identify individuals who have developed an immune response to the virus by detecting the presence of antibodies in the blood – if antibodies are present, that indicates that the person has been exposed to the virus and developed antibodies against it, which may mean that person has at least some immunity to the coronavirus. In the early days of an infection when the body's immune response is still building, antibodies may not be detected, which is why serological tests should not be used as the sole basis to diagnose or exclude infection with the SARS-CoV-2 virus.

There is still a great deal about COVID-19 immunity that we don't yet fully understand. For example, we don't yet know that just because someone has developed antibodies, that they are fully protected from reinfection, or how long any immunity lasts. We do expect that data from more widespread serological testing will help us track the spread of the virus nationwide. Determining the next steps in our response to COVID-19 is partially dependent on an accurate assessment of our national efforts thus far, and the quality of data for making this decision is dependent on accurate testing products.
 

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