In an effort to rapidly increase U.S. capacity to test for monkeypox, the Food and Drug Administration is building on lessons learned from the rapid adoption of Covid-19 tests and relaxing regulations so test developers get an emergency use authorization, a decision applauded by the industry’s largest trade group.
Now, the FDA is exempting certain lab-developed tests from the EUA requirements that were in place for Covid test developers. In a recent directions, the FDA wrote that it does not plan to require authorization for PCR tests that are performed by a CLIA-certified laboratory and use lesion swabs for sample collection. Developers must always notify the agency within five days of offering the test and share proof that they have passed the test.
The American Clinical Laboratory Association, which represents several major testing companies, supported some of the decisions.
“We believe that some important aspects of EUA policy reflect lessons learned from Covid and the state of the public health emergency with monkeypox, which includes how, through clinical laboratories, there is currently a capacity important test, greater than the request. right now,” CAWA President Susan Van Meter said in a phone call.
Van Meter said the test “patterns” published by the FDA to help developers understand the performance characteristics they are looking for would be helpful. The agency created something similar for Covid testing, but released it after the EUA policy came into effect.
At a meeting Wednesday, Toby Lowe, associate director of regulatory programs for the FDA’s Office of In Vitro Diagnostics, said the agency doesn’t expect to get the actual data for these lab-developed tests, but only asks laboratories to confirm that they have correctly validated their assays.
“We intend to contact a lab if we receive any signals that there is an issue or concern with a test,” Lowe added.
While the guidelines largely focused on PCR tests that use a skin lesion swab sample, the FDA is working on a model for rapid antigen testing, said Timothy Stenzel, director of the FDA’s Office of In Vitro Diagnostics. FDA.
Stenzel recommended that test developers interested in this route contact the Independent Test Review Program, which was created by the National Institutes of Health to expedite regulatory review of over-the-counter Covid tests. Rapid antigen tests must be validated on real patient material, he added.
Labs that use other types of samples, such as blood or saliva, must notify the agency, Stenzel said. In its guidelines, the FDA has requested validation data to support any other sample type as part of EUA submissions.
ACLA’s Van Meter said the agency appears to be interested in encouraging home testing for monkeypox.
“Generally, anytime we can reduce barriers for individuals to get the tests they need, that’s important,” she said. “And sometimes that means making sure the science is correct and the tests can be validated with a sample taken by the patient.”