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- FDA Gives Update on Monkeypox Testing and LDTs
During an open call with laboratories on August 15, officials with the Food and Drug Administration (FDA) said laboratory-developed tests (LDTs) for monkeypox disease are under enforcement discretion and can be developed without notifying the FDA.
The CAP attended the Laboratory Outreach Communication System call managed by the Centers for Disease Control and Prevention (CDC). The clarification on LDTs follows the United States’ declaration of monkeypox as a public health emergency.
FDA Director of the Office of In Vitro Diagnostics Timothy Stenzel, MD, PhD, said the FDA is considering what processes and policies would be needed if the agency issued an emergency declaration. The FDA would release guidance documents similar to those released during the coronavirus pandemic. It would have a template for test submission requiring 30 positive and negative samples. However, due to the difficulty of obtaining samples, laboratories and manufacturers could use contrived specimens for validation.
If an LDT is currently on the market before an emergency use authorization (EUA) is issued, the LDT would be allowed to remain on the market as the FDA implements its monkeypox EUA testing guidance.
The CAP will monitor FDA activities and notify its members if the agency takes further action.
Previously, the Centers for Disease Control and Prevention (CDC) had released guidance on reporting test results and specimen collection. The government has worked to overcome issues with specimen collection as laboratories have reported enough capacity to test for the disease.
During the CDC call, officials said the US leads the world with more than 11,000 monkeypox cases. Along with reviewing guidance on specimen collection, the CDC provided resources on validation materials for the disease developed by the National Institute for Standards and Technology and BEI Resources.