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FDA Will No Longer Review EUA Submissions for SARS-CoV-2 Lab-Developed Tests

NEW YORK – The US Food and Drug Administration announced on Wednesday it will no longer review SARS-CoV-2 Emergency Use Authorization submissions for lab-developed tests.

In the latest of its weekly virtual town hall sessions, the agency asserted that the change is consistent with the recent statement by the US Department of Health and Human Services and will also help FDA prioritize the review process during the pandemic.

On the call, Timothy Stenzel, director of the Office of In Vitro Diagnostics and Radiological Health at FDA's Center for Devices and Radiological Health, summarized a statement from the agency's FAQ page and provided additional comments.

"We are currently in a different phase of the pandemic with respect to tests than we were previously," he said, noting that the FDA has authorized more than 250 tests to be run in labs, and more than 400 are offered under the agency's notification pathway.

FDA continues to prioritize review of EUA requests for point-of-care tests, home collection tests, at-home tests, tests that reduce reliance on certain types of test supplies, and high-throughput, widely distributed tests, Stenzel asserted.

HHS, which oversees the FDA, determined in late August that FDA cannot not require premarket review of laboratory-developed tests without notice and comment rulemaking, a move that took many in the industry by surprise as it upended FDA's role in LDT regulation.

"In light of [FDA's priorities] and the recent HHS announcement that FDA will not require premarket review of LDTs, to make the best use of our resources for the greatest public health benefit, FDA is declining to review EUA requests for LDTs at this time," Stenzel said, quoting from the agency's FAQ page.  

Additionally, Stenzel said that the approach "will provide greater potential to improve the national testing capacity and permit FDA to take appropriate steps to ensure that authorized tests may be effective."

The approach will apply to new EUA submissions, as well as those already in the pipeline for review.

"There were a few, as we approached this new policy, that we finished up, because they were so close to the finish line and we had worked closely with those [developers], and in fairness it seemed the right thing to do," Stenzel said. "For those that were further out from potentially being authorized, we are going to decline to review those LDT applications."

A caller from a high-complexity lab noted his group had submitted an LDT several months ago and recently submitted responses to FDA's feedback. That type of submission will now be declined, Stenzel said. "If you haven't received an EUA authorization already, then we will from here forward be declining to review any LDTs," he said.

Once the agency generates a list of pending LDT EUAs it will send a letter to developers to let them know, Stenzel said. "We are going through our submissions and determining which tests are LDTs, and they will get a letter as soon as we can get that out to them," he said. 

A caller asked whether developers would not be able to get Public Readiness and Emergency Preparedness (PREP) Act coverage for their test. In reply, Stenzel read a prepared question: "Is this an FDA effort to prevent LDTs for COVID-19 from getting PREP Act protection?"

Stenzel's reply to this prepared question was, "No, this is an effort to prioritize FDA resources for the greatest public health benefit considering the extent to which we can use our authorities under the Food, Drug, and Cosmetics Act."

In a statement, Julie Khani, president of the American Clinical Lab Association, noted that many of the tests that have already been granted EUAs for COVID-19 testing are "innovative, high-throughput LDTs that have reduced reliance on supplies and been integral to expanding testing capacity," and that these are the kinds of tests that FDA has stated it wants to prioritize. 

"ACLA believes the FDA should continue to allow labs to voluntarily submit EUAs for FDA review and authorization," Khani said.

Other town hall topics

In addition to LDTs, the agency provided insights into the potential for tests to transition from EUA to a de novo pre-market approval or 510(k) cleared pathways.

"We have three teams – a serology team, a direct antigen team, and a molecular team – and they divvy up the applications by technology so that those that are most experienced in [particular] technologies are involved in review of those technologies," Stenzel said. "We are very open to receiving test submissions for full authorization. ... Our staff are doing double duty – the experts in our office who are reviewing EUAs are also going to be reviewing de novo's and 510(k)s for COVID tests, and in addition our office is still handling all the usual, and roughly the same amount that we saw last year, of non-COVID test submissions that come to our office."

Regarding reference panel testing of EUA tests, "It is a condition of all authorizations of all tests that when we request that you do a panel testing that you do that and report the results to us," Stenzel said.

The panels can potentially be shipped outside of the US, he also said. "I know that we tried to ship internationally, but there have been some shipment problems going through customs and things like that," Stenzel said, but, he said developers may be able to find a way to map out a shipping strategy to get the panel to another country "in enough time so that dry ice is still on the samples."

In response to a question from a developer of a combination SARS-CoV-2 and influenza antigen test, similar to one recently authorized from Quidel, for which neither target has previously been authorized or cleared, Stenzel noted that there is multianalyte guidance in the FDA's template for molecular diagnostics but that there is no such guidance yet in the antigen testing template.

"I believe the team is ready to be able to give specific feedback on our recommendations based on our current thinking around this for direct antigen tests, so simply email" us, he said. Stenzel also noted that there will likely be a "greater expectation of validation" if a test hasn't been seen by the agency before and received authorization for the non-SARS analytes. For pre-market review, the fact that it is not yet the peak of flu season could be an obstacle for developers needing to prospectively validate a novel test with a flu component, so the agency is prepared to accept validation studies using banked samples, with potential for a commitment for a post-market prospective study.

And, Stenzel asserted again this week that there has yet to be a fully at-home diagnostics test for SARS-CoV-2 — molecular or antigen testing — submitted to FDA for EUA review.