FDA EUA for Monkeypox LDT
Hi,
The FDA has published procedures for high complexity laboratories to be able to develop PCR tests for monkeypox/orthopoxvirus and get them approved under EUA. So far only Quest is listed, but one of our large hospitals is nearing completion of their test.
Our State PHL Director mentioned this on an internal monkeypox call we have. He also mentioned the possibility of antigen tests (yikes).
I'm assuming that if one of these labs is using AIMS, then the commmunity will be notified.
I'll mention on the extended ELR weekly call - if this is old news, apologies!
Monkeypox Emergency Use Authorizations for Medical Devices | FDA
The FDA has published procedures for high complexity laboratories to be able to develop PCR tests for monkeypox/orthopoxvirus and get them approved under EUA. So far only Quest is listed, but one of our large hospitals is nearing completion of their test.
Our State PHL Director mentioned this on an internal monkeypox call we have. He also mentioned the possibility of antigen tests (yikes).
I'm assuming that if one of these labs is using AIMS, then the commmunity will be notified.
I'll mention on the extended ELR weekly call - if this is old news, apologies!
Monkeypox Emergency Use Authorizations for Medical Devices | FDA
I'm curious if FDA/APHL/CDC is considering a LIVD file for these orthopoxvirus/non-variola orthopoxvirus/monkeypox virus EUA assays?
Nicole Kikuchi, MPH, CPM
Surveillance Epidemiologist
Bureau of Epidemiology
Division of Disease Control and Health Protection
Florida Department of Health