AOAC SPADA Meeting

IN SILICO ANALYSIS & DIAGNOSTICS

Regulatory

• Inclusivity/Exclusivity o

Can be useful for “rule in”; hard to use for “rule out”

• BSAT Biological Material o Minimized wet lab testing o Required increased sophistication in evaluation  in silico predictions o Expected non‐BSAT organisms to be wet lab tested o Significant challenge – lack of generally accepted method to:  Validate theory  Develop acceptance criteria • Mock Clinical trials o Actual bacterial agent; synthetic construct for viral targets possible • Balance Risk with Burdon

UNCLASSIFIED

20181017_SPADA_In silico Analysis & Dx

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IN SILICO ANALYSIS & DIAGNOSTICS

Post-Market Surveillance

• May be implemented as a ‘warning light’ indicating probability of diagnostic failure o Rapid, agnostic method to identify heterogeneity in primer/probe binding  regions • Assessment of newly sequenced isolates vs fielded assays o Outbreaks o Combination of rapid sequence availability, synthetically manufactured  templates, and  in silico analysis enabled high confidence that the fielded  EBOV assays would be effective with the current outbreak • Wet-lab test as needed o Analysis may reveal critical or marginal affects on predicted PCR  performance o May be useful to have guidelines/criteria for recommending wet‐lab testing

UNCLASSIFIED

20181017_SPADA_In silico Analysis & Dx

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