FDA issues emergency guidance to spur development of monkeypox tests

Regulatory NewsRegulatory News | 09 September 2022 |  By 

The US Food and Drug Administration (FDA) issued an immediately effective guidance and a corresponding FAQ to spur the development of new monkeypox diagnostics during the public health emergency. The agency said there is a need for new private sector tests, as the only currently cleared diagnostic is one developed by the Centers for Disease Control and Prevention (CDC).
Alongside the announcement, the agency issued the first emergency use authorization (EUA) for a monkeypox test, the Quest Diagnostics Monkeypox Virus Qualitative Real-Time PCR, which detects monkeypox and other non-variola orthopoxvirus DNA via lesion swab specimens.
The guidance comes a month after Health and Human Services Secretary Xavier Becerra declared monkeypox a public health emergency. While the disease is not yet endemic in the US, the number of reported cases has topped 21,000 and public health officials have been criticized for not responding more aggressively to stem the disease’s spread.
The guidance and FAQ detail FDA’s review priorities for EUA requests for monkeypox diagnostics and describe its enforcement policies for certain diagnostic tests that are developed and performed by Clinical Laboratory Improvement Amendments (CLIA) certified laboratories that can perform high-complexity tests. It also provides recommendations for diagnostic test validation, describes the agency’s enforcement policies for cleared or authorized monkeypox diagnostic tests that are modified and describes enforcement policies for certain serology tests.
These “important actions further aid the monkeypox response by working toward expanding vital testing capacity and facilitating the detection of cases nationwide in an effort to stem the spread of the virus,” said Center for Devices and Radiological Health Director Jeff Shuren. Currently, the CDC-developed Non-variola Orthopoxvirus Real-time PCR test is the only cleared test available in the US.
“However, the United States Government believes there are additional, critical needs for monkeypox tests at this stage of the outbreak,” the agency said. “The policies in this guidance are designed to address those testing needs and account for the importance of expanding availability of tests and addressing future potential testing needs.”
The agency said it will monitor the outbreak and testing landscape in the United States and will “revise its policies and recommendations as appropriate.” It also noted that the policies, validation recommendations and other recommendations should be considered for initial testing of patient specimens and confirmatory testing should be performed as needed.
FDA also noted that its enforcement policies do not address medical device reporting (MDR) regulations for tests offered prior to or without authorization as described in the guidance. However, monkeypox test developers are expected to comply with MDR requirements during the public health emergency, including reporting of adverse events that reasonably suggest that a test may have caused or contributed to death or serious injury, and malfunctions that may cause or contribute to death or serious injury.
“Moreover, unless and until an EUA (or marketing authorization with accompanying CLIA categorization) is issued that authorizes additional testing environments for a specific test, under CLIA, use of that test is limited to high-complexity CLIA-certified laboratories, including testing at the point-of-care when the site is covered by the laboratory’s CLIA certificate for high-complexity testing,” the agency added.
Regulators said they plan to prioritize review of EUAs for high-throughput diagnostic tests, tests with home specimen collection, or rapid diagnostic tests, from experienced developers with high manufacturing capacity who let FDA know within 30 days of the guidance’s publication that they indent to file for an EUA.
FDA said it will not object to monkeypox tests developed and performed by CLIA-certified labs with the ability to run high-complexity tests for the time being, so long as the tests use molecular polymerase chain reaction (PCR) technology and lesion swabs. FDA said that such tests must be appropriately validated, and developers should notify the agency withing five business days of offering the tests of their intention and that they have appropriately validated the test. The policy for laboratory-developed tests does not apply to tests with home specimen collection, tests that use specimen types other than lesion swabs or technologies other than PCR.
The regulators are also giving a lot of leeway to certain CLIA-labs to modify and administer tests to allow availability of more monkeypox tests.
“When a high-complexity CLIA-certified laboratory is modifying a cleared or authorized monkeypox molecular diagnostic test, including one for which such laboratory is not the developer of the original test, and the modifications do not change the indication for use set forth in the 510(k) or EUA (e.g., including new/different extraction kits or instruments that would not be expected to change the indication for use) and do not change the analyte specific reagents (e.g., the modifications do not change the PCR primers and/or probes or enzymes), FDA does not intend to object to implementation of the modification to the diagnostic test without a new or amended EUA or a new premarket submission (e.g., 510(k)) where the test has been validated, the validation demonstrates that the modifications do not adversely affect test performance, and the laboratory submits notification of validation to FDA,” the agency said.
Statement, Guidance


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