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Post-EUA Regulatory Landscape for COVID-19 Tests Coming Into View, But Details Remain Fuzzy


NEW YORK – While COVID-19 infections remain widespread, there are indications that the pandemic phase of the outbreak is drawing to a close, and as it does, many expect the US Food and Drug Administration to wind down the Emergency Use Authorization (EUA) issuance under which most clinical labs and test vendors have been operating.

A few diagnostics firms have already moved to take their COVID-19 tests through the standard de novo or 510(k) regulatory pathways, but many are waiting as they continue to assess the potential market for their tests and look to the FDA for further guidance.

In December, the FDA issued a draft guidance laying out a plan for transitioning from EUA to de novo or 510(k) clearance of COVID-19 tests. Under the guidance, which remains only a draft, notice of termination of the relevant EUAs will be published in the Federal Register 180 days before the date of termination. Companies who wish to continue marketing their tests following the end of the EUA will have to make and have accepted by the FDA a marketing submission (de novo or 510(k) depending on whether a cleared predicate device for a particular test exists) by the EUA termination date. Once a submission has been accepted, vendors can continue to sell a test after the EUA termination date while the FDA evaluates the submission provided they update their product labeling to state that the test was authorized under an EUA and is under FDA review.

Given this proposed transition plan, there would seem to be little incentive for companies to make submissions before notice of the EUA termination is published. Several firms, including Abbott, which offers COVID-19 tests in a variety of formats, and home test vendor Ellume, declined to comment on their plans for marketing their tests following the end of the EUA.

Meanwhile, Siemens Healthineers, which like Abbott, offers antigen and molecular COVID-19 testing, said in a statement that it "is committed to providing COVID-relevant tests needed by clinicians as we move from a pandemic to endemic phase."

"We are evaluating the need in real-time as this dynamic market continues to evolve and the regulatory conditions change," the company added. "We expect to be able provide the needed tests after the EUA period expires and will pursue the appropriate regulatory pathways as required."

Jeff Gibbs, a director at the law firm Hyman, Phelps & McNamara, who formerly served as the FDA's associate general counsel for enforcement, suggested that many firms may still be evaluating what tests they will want to bring to market after the EUA issuance ends.

"I'd be thinking about what are the commercial products that I am going to want to have," he said. "I don't know that I'd want to put everything through a 510(k) if I have multiple [COVID-19 tests]. What would be the most appealing?"

For instance, Gibbs said, companies may decide that in coming years much COVID-19 testing will be done as part of panels that simultaneously test for multiple respiratory viruses and will therefore prioritize those assays for transition from EUA to 510(k).

Many companies, in fact, have voluntarily stopped marketing and distributing their COVID-19 tests that had received EUA from the FDA and asked the agency to revoke the authorizations. In at least some cases, the tests did not find market traction. In other instances, a company chose to "transition" to the use of another of the firms' COVID-19 tests.

Gibbs also said that firms are likely waiting for additional information or a finalized guidance from the FDA before moving ahead with pursuing full regulatory approval for COVID-19 tests.

"It's hard to do anything concrete unless you know what FDA wants," he said.

One question vendors may have, he gave as an example, is the issue of how the FDA will weigh the real world evidence that has been collected on many tests outside clinical trials over the course of the pandemic.

In an email, an FDA official said that the agency "is open to considering existing real world evidence supporting a regulatory submission."

"If test developers have real-world evidence that can be used to establish the performance of their test, we recommend that they engage in a discussion to appropriately leverage real world use and experience as part of their marketing application," the official added.

In a March 23 letter providing comments on the FDA draft guidance, medical device trade association AdvaMed, made several suggestions, including that the agency "consider development of a standard template of information and data expectations for certain high volume EUA devices," which it noted could lighten and speed the agency's review process.

The FDA has issued de novo authorization or 510(k) for two COVID-19 tests, BioMérieux's BioFire Respiratory Panel 2.1 (de novo on March 17, 2021) and its BioFire COVID-19 Test 2 (510(k) on Nov. 1, 2021). The decision summaries for these tests provide an indication of the evidence the agency is looking for in future COVID-19 510(k) submissions. To support its submission for the BioFire COVID-19 Test 2, BioMérieux collected 534 specimens across three study sites where COVID-19 prevalence ranged from 8 percent to 16 percent. The test performed with 98.6 percent sensitivity and 99.6 percent specificity compared to the comparator device, the BioFire Respiratory Panel 2.1.

Other companies have made de novo submissions, including Chembio Diagnostics in December 2021 for its DPP SARS-CoV-2 Antigen test and Cue Health this month for its Cue COVID-19 Test home-based molecular assay, but FDA has not issued rulings on these submissions yet.

While few test makers have looked to get a head start on the process, Cue Health CEO Ayub Khattak said that as a company targeting the home market, his firm saw de novo authorization as a competitive advantage in a space where test performance has sometimes been an issue.

"I think one of the hallmarks of COVID is that people didn't know what information to trust, and there has been so much confusion about what the qualities of each test are," he said. "That confusion can be clarified when there is a cleared test because at that point it means it meets FDA's stringent standards for an actually authorized product as opposed to one that is authorized under the duress of an emergency."

Another question raised by the American Clinical Laboratory Association (ACLA), in a March 1 letter commenting on the FDA draft guidance, is how the agency will treat laboratory-developed tests for COVID-19 developed following the termination of the EUA. In its letter, ACLA asked the FDA to "recognize [its] longstanding exercise of enforcement discretion regarding LDTs and expressly clarify that such COVID-19 LDTs will not require any FDA authorization upon termination of the relevant EUA Declaration."

The FDA official declined to comment on this question in their email to 360Dx. Depending on when the COVID-19 EUA ends, the issue could be impacted by congressional action on the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which would resolve decadeslong questions around the FDA's authority to regulate LDTs, bringing them under the agency's authority. A number of observers believe the bill could pass this year, likely as part of a larger package reauthorizing the Medical Device User Fee Amendments.

When the COVID-19 EUA period will end remains unclear. EUAs for the Zika virus and Ebola began in the middle of the last decade and are still ongoing. Gibbs suggested, though, that the COVID-19 EUA is likely to wind down sooner rather than later given how broadly it has impacted the country's healthcare system and how political an issue the virus has become.

In the meantime, though, EUA applications for COVID-19 tests continue to pour in. During the FDA's town hall meeting for COVID-19 test developers on April 20, Timothy Stenzel, director of the agency's Office of In Vitro Diagnostics and Radiological Health, said it was still seeing around 130 applications per month.