The question of whether the U.S. FDA will review emergency use authorizations (EUAs) for lab-developed tests (LDTs) for the COVID-19 pandemic has bounced around frequently in recent weeks, and Brett Giroir of the Department of Health and Human Services has resurrected the issue. In a Nov. 16 press briefing, Giroir pressed the FDA to resume reviews of LDTs under the EUA program, but his remarks made clear that he was focused on liability protection for university clinical labs that will be screening college students as they leave for and return from home for the Thanksgiving break.

The question of whether the FDA is statutorily authorized to regulate LDTs has also been topical, and was the subject of a recent analysis by the general counsel at the Department of Health and Human Services. This presumably was the justification for an HHS announcement that declared that the FDA could not force labs to file EUAs, although the signals emerging from the FDA in the weeks that followed were sometimes mixed. One of the key provisions of the HHS rescission, however, is that any LDTs that do not go through the EUA program are not exempt from product liability litigation, although a Harvard professor of epidemiology said recently that Giroir was considering some means of providing that very exemption from LDTs broadly.

Giroir, who serves as the Assistant Secretary for Health, said in a Nov. 16 press briefing that all LDTs can be used without any action on the part of the FDA, but he staked out his concern about colleges and universities as this latest wave of COVID infections rolls out. “What we’re speaking about is really whether universities primarily will be given the same liability protections as major corporate developers and manufacturers, and we want that to be the case,” Giroir said, adding that he had communicated with FDA commissioner Stephen Hahn on the question. Giroir added that he had sent a memo to FDA device center director Jeff Shuren about how to proceed.

“Although these new LDTs will not make a significant impact on the nation overall, they are critically important – especially now with the rise in cases – to many universities, university towns and nonprofit institutions throughout the country,” Giroir said.

FDA’s FAQ does not acknowledge Giroir

The FDA posted a number of updates to its FAQ for testing, including one regarding the agency’s priorities for reviewing EUA submissions. The update said that many COVID tests are already authorized to run in labs, and that the agency continues to prioritize tests that offer greater access, such as point-of-care tests. Testing capacity continues to be a point of emphasis as well, but the agency said it is still declining to review EUA requests for LDTs “at this time.”

This policy, the agency said, is to help the FDA make the best use of its resources, adding that it will consider supplemental requests for modifications to existing LDT EUAs.

The news comes at a ticklish time as the surge in COVID-19 cases just ahead of the Thanksgiving holiday has labs scrambling to meet demand. Quest Diagnostics Inc., of Secaucus, N.J., said in a Nov. 17 press release that orders for the company’s molecular testing have risen by roughly 50% compared to the last week of September, and that the positivity rate has risen above 10%, which limits the ability to pool specimens for more efficient use of resources.

A concomitant increase in demand on supplies is again crunching the ability of labs to meet demand, and Quest said its average turn-around time for molecular testing for all patients is again longer than two days. For priority patients, turn-around may be as long as two days, a figure that was down to one to two days as recently as the second week of November.

AMP says put it in writing

Mary Steele Williams, executive director of the Association for Molecular Pathology (AMP), told BioWorld that the association “commends the many community and academic medical center laboratories that have worked diligently to validate and offer quality SARS-CoV-2 diagnostic testing during this pandemic, despite the extreme supply shortages and unprecedented demand.” Williams said, however, that AMP would like to see some clarification regarding the statements by Giroir, which she said should be in writing.

Williams pointed to the Nov. 16 update to the FDA’s EUA webpage as failing to “reflect these new policy changes,” and recommended that HHS make use of existing Clinical Laboratory Improvement Amendments (CLIA) authorities for additional support. “CLIA already regulates laboratories that perform testing on patient specimens in order to ensure accurate and reliable test results. Because of this, CLIA is best positioned to provide oversight for LDTs for COVID-19 and other laboratory tests,” Williams said.

Julie Khani, president of the American Clinical Laboratory Association (ACLA), told BioWorld that many, “of the tests that have 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.” Khani reiterated ACLA’s position that such tests “are exactly 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,” she said.

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