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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