August 30, 2016 SPADA Meeting Book

Diagnostics Developed • CDC developed/evaluated (real time) PCR assays targeting Orthopoxvirus genus and various species ( Variola, Monkeypox, Vaccinia , etc. ) – Provide reagents/facilities for others to evaluate assays • ~Thirteen peer-reviewed publications evaluate PCR assays against authentic Variola virus genomic material • Subset used in LRN ( Variola, Monkeypox, Cowpox and Vaccinia virus detection) • Regulatory agency approval De novo 510K submitted on Orthopoxvirus non variola assay – - • Approved September 2012 – Discussion initiated with FDA (2002) on Variola virus assay • Submission on newly validated assays in 2016 • Initiating, technology transfer to other countries – Monkeypox – Smallpox laboratory diagnostics network (WHO sponsored) – 2002 onward: vaccine AE identification – 2003: response to monkeypox outbreak Clinical Diagnostic Approaches used at the WHO CC at CDC • Nucleic acid testing • Viral isolation • Serologic assays • Protein based/virus detection – In development – Commercial assay available • Only one Orthopoxvirus diagnostic assay has achieved regulatory approval – LRN Orthopoxvirus non-variola real-time PCR assay • FDA de novo 510(k) approved September 2012 • Dependent upon LRN algorithm