COVID-19 Conundrum: What FDA is Doing About Urgent Need For Coronavirus Testing

First, though, some background. In the latter part of 2019 and the beginning of 2020, US health policy leaders and the Centers for Disease Control and Prevention decided that, unlike other countries in the world, CDC would develop its own test for the US and that this CDC test would be the only test available. There were problems with the development of this test initially, but finally, on February 4, 2020, the FDA issued an EUA (an Emergency Use Authorization) for the CDC test. However, as the pandemic proceeded, it soon became apparent that having only one test available in the US was woefully inadequate – or as the FDA puts it, “the severity and scope of the current COVID-19 situation around the globe necessitates greater testing capacity for the virus than is currently available.”

Therefore, about a month later – on February 29, 2020 – the FDA published a Guidance document to greatly expand the EUA process to make it available to other entities so as to “to help rapidly expand testing capacity by facilitating the development and use of SARS-CoV-2 diagnostic tests during the public health emergency.” This Guidance was finalized on March 16, 2020.[1]

This Guidance sets forth essentially three policies for accelerating the development of certain laboratory tests for COVID-19. These can be summarized as “Clinical Laboratory,” “State Laboratory,” and “Commercial Laboratory” tests. We will briefly describe each in this Alert, but one requirement of each is that whatever test is developed first must be “validated” – that is, the entity developing it must show that the test will do what it is designed to do. FDA has set forth in the Guidance, at pages 9-11, the principles of Validation it expects each entity to follow.

Clinical Laboratory Tests

The first policy applies to laboratories certified under the Clinical Laboratory Improvement Amendments. FDA says that it will now allow CLIA laboratories to develop and perform diagnostic tests to detect the SARS-CoV-2 virus so long as, afterward, they submit an Emergency Use Authorization to the FDA. The laboratories are required to notify the FDA when their assay has been validated and then they must submit a completed EUA request within 15 business days of the initial communication to FDA. While they are doing so – and while the FDA is reviewing the EUA – FDA says that, in an exercise of enforcement discretion, it will not object to the use of the test for specimen testing – which means that testing can proceed. FDA requests that the laboratories report results from the serological testing and that they report positive results immediately to appropriate Federal, State, and local public health agencies. In addition, while awaiting the FDA determination on the EUA request, FDA asks that the first five positive and the first five negative clinical specimens be tested against an EUA-authorized assay.

State Laboratory Tests

FDA is now saying that it will also allow states and territories that authorize laboratories within their borders to develop their own COVID-19 tests and perform specimen testing. The state or territory would do this under the authority of its own laws. This was first allowed on March 12, 2020, with the Wadsworth Center in the State of New York. The tests developed under this policy would not need an EUA so long as the state or territory “takes responsibility for COVID-19 testing by laboratories in its State during the COVID-19 outbreak.” FDA says that it is willing to work with the state or territory laboratories to develop these tests and has asked that they notify the Agency when they have started clinical testing.

Commercial Laboratory Tests

As a further expansion of the development of tests, FDA is also now saying that commercial manufacturers may develop and distribute diagnostic test kits. However, these test kits can only be provided to other clinical laboratories and to healthcare workers for point-of-care testing, not for home testing. Once again, FDA announced that it will exercise its enforcement discretion for a reasonable time (15 business days) after the manufacturer’s validation of the test while the manufacturer is preparing its EUA request so that the test can be marketed and used. The exercise in enforcement discretion will last until the FDA rules on the EUA request.

FDA is further announcing in the Guidance that commercial manufacturers can develop and distribute serology tests without an EUA. Serology tests identify antibodies from clinical specimens but the manufacturer must notify recipients that negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus, and that results from the serology tests should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection.

The loosening of the FDA requirements under this Guidance has already had the effect of allowing tests other than the CDC test to be used in the United States, thus facilitating much more widespread testing in the country.

[1] The Guidance is entitled “Policy for Diagnostic Tests for Coronavirus Disease – 2019 during the Public Health Emergency: Immediately in Effect Guidance for Clinical Laboratories, Commercial Manufacturers, and Food and Drug Administration Staff.” It can be found here.