Many of the developers of in vitro diagnostic tests will seek to convert their emergency use authorizations (EUAs) to conventional premarket filings, and Tim Stenzel, director of the U.S. FDA’s Office of In Vitro Diagnostics and Radiological Health (OIR), said a draft guidance for this conversion is in process. However, Stenzel said he could not predict when that draft might emerge, given that the agency is still scrambling to keep up with both EUA and conventional applications.
Stenzel did not address the Nov. 16 remarks by Assistant Secretary of Health Brett Giroir that university clinical labs are in need of EUA review for their tests in order to avoid litigation over testing of students. He also declined to respond to one caller regarding the absence of a geographically and circumstantially uniform U.S. testing policy, stating that he has been “a good soldier” who has been tasked with providing access to accurate testing via the EUA program.
The first COVID-19 tests that undergo a conversion from an EUA filing to a conventional premarket review mechanism are likely to have to resort to the de novo mechanism for risk classification. Following completion of a granted de novo petition, other sponsors will have a predicate for that test type, which enables the use of the 510(k) program, a substantially less cumbersome process than the de novo mechanism. Stenzel also reminded attendees that the grant of a de novo petition is packaged with a clearly characterized set of special controls that sponsors can use to guide their development efforts.
However, Stenzel acknowledged, “we are inundated with both COVID-related applications and our normal volume of non-COVID applications” for review. While the agency is keen on providing more specific guidance for EUA conversion, the focus is still on processing “the many, many EUA applications that we have” on hand already, he said. A good example of this process can be seen in previous diagnostic EUA conversions for tests directed toward respiratory viruses, but Stenzel steered clear of promising a date for the EUA conversion draft guidance.
New templates in the works
Stenzel said the FDA has not published a template for serology tests for home sample collection or for home testing, but these topics are the subjects of a draft template that has cleared his desk. When that template will be made public is not clear, but in the interim, sponsors can communicate with the agency on the sort of data that would be needed.
One caller suggested that the pace of EAU authorizations has slowed in recent weeks, and inquired as to whether this was due to a resource crunch vs. a rethink of the process. Stenzel said that while the agency does not publicize denials of EUA applications, “there has been an increase in the number of denials” in recent weeks. The agency has brought staff in to OIR from other offices to help speed up the EUA process – the number of FDA staff reviewing testing EUAs has increased by more than 100%, Stenzel said – but the requisite training has made another set of demands on the experienced members of the OIR staff. One consequence of this shift has been to hamper the processing of non-COVID applications. Still, the personnel surge “will result in more speedy reviews going forward,” he said.
Stenzel said that the issue of forwarding the results of home COVID-19 testing to government agencies is out of the FDA’s hands, adding that he is not aware of a specific legal requirement that a home use test kit automatically forward results to a local, state or federal government agency. This type of question might be better handled by the CDC or the Centers for Medicare & Medicaid Services, he said.
“For home tests, we ask developers to give us your thoughts about how you might make it possible to report those results, but we don’t make it a review requirement” under the EUA program, Stenzel said. This capability can be incorporated into an EUA filing with the test, but Stenzel advised that development of this type of app outside the EUA program would cause that app to be regulated as software as a medical device, which carries a distinct set of regulatory requirements.
New COVID program at NCI
The U.S. National Cancer Institute (NCI) has been involved in the federal government’s response to the pandemic for some time, principally by assisting the FDA in validation of serology tests for the SARS-CoV-2 virus. However, the NCI’s Frederick National Laboratory (FNL) in Frederick, Md., has gone a step farther and assembled a network of labs to answer questions about the pandemic, such as the volume of antibodies to the virus are associated with protection from COVID-19.
In a Nov. 17 statement, the FNL explained that it has brought together scientists from 25 of the top biomedical research institutions in the U.S. to answer questions such as the association between antibody levels and the level of protection such levels confer. This consortium, dubbed the Serological Sciences Network (SeroNet), builds on a similar effort in connection with human papillomavirus, and includes centers of excellence such as Emory University in Atlanta. Emory and the other centers of excellence are developing a more thorough understanding of the immune system response to the SARS-CoV-2 virus, while another 13 projects are dedicated to applied and basic serological research for the pandemic. Data from all these programs will be publicly available in a database that is currently under development.
Ligia Pinto, director of the SeroNet program, said the network arrangement “will facilitate idea generation and enable us to share what we discover with the community faster than if each institution were working alone.”