On May 4, 2020, the U.S. Food and Drug Administration (“FDA”) announced new restrictions on the marketing and distribution of serology tests used to identify antibodies to COVID-19 during the course of the public health emergency. Such tests, which can quickly indicate whether someone has been exposed to a particular pathogen, such as COVID-19, could prove critical in determining the level of population that has been exposed to the virus and has potentially developed immunity to further infection.
In an effort to allow valid tests to quickly become available, since mid-March, FDA had allowed for the manufacture and distribution of such tests without specific FDA approval, so long as the manufacturer (i) notified FDA of its intent to distribute the tests, (ii) affirmed that the tests were validated, and (iii) provided instructions for use containing required disclaimers, including that the test had not been reviewed by FDA and should not be used as the sole basis to diagnose an infection. However, since the publication of that policy, significant questions were raised about the validity and proper use of at least some tests being marketed.
In response, FDA published the new restrictions, outlined in FDA’s Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency (revised May 4, 2020). The revisions make significant changes to the agency’s policy on COVID-19 antibody tests. Under the new guidance, FDA will now require the manufacturer or distributor to submit an Emergency Use Authorization (“EUA”) request and FDA will independently verify the manufacturer’s validation data. The new policy still allows for the distribution of validated tests prior to receiving an EUA, but companies must now prepare and submit an EUA within approximately 10 business days of distributing the tests. To help facilitate the process, FDA has developed an EUA template that is specific to such serology tests. If FDA identifies any concerns while reviewing an EUA submission, the agency has committed to providing companies with an opportunity to address any issues before initiating an enforcement action. If the manufacturer fails to file an EUA request within approximately 10 business days of beginning distribution, distribution is no longer authorized and must cease.
In addition to approving EUAs for individual tests, FDA has also issued an umbrella EUA for all antibody tests that have been independently validated by the National Institutes of Health’s National Cancer Institute or any other agency that FDA has designated to conduct such validation. Companies may voluntarily submit their test to the National Cancer Institute for independent validation and, if deemed eligible by FDA, may request that their test be added to the umbrella EUA. The National Cancer Institute has so far conducted validation testing on 13 antibody tests but has not yet released the data publicly.
Companies seeking to manufacture and distribute COVID-19 antibody tests are advised to engage FDA for a pre-EUA review early in the development process and should consider submitting their tests to the National Cancer Institute for independent validation. Companies who do so will be asked to sign a transfer agreement allowing that the test results be made publicly available. As of this writing, FDA has approved EUAs for 12 antibody tests and is currently reviewing submissions for an additional 200 tests. Distributors and consumers of antibody tests are advised to consult FDA’s website to ensure they are purchasing tests that have been properly validated. Those antibody tests that have received EUAs may be found on FDA’s website: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.