•   Potential challenges to consider:

o   Integration of multiple components or technologies (“detection is done”).

o   Effectively maximizing sample concentration and minimizing sample contamination (sample to environmental background).

o   High-quality databases, bioinformatics tools, and assay validation are needed for all technologies.

•   A multidimensional approach is encouraged:

o   Technologies using immunoassays and mass spectrometry are fast; nucleic-acid approaches and genome sequencing can provide specificity and identify novel threats.

o   Orthogonal testing increases the reliability of a BioWatch Actionable Result (BAR) and confidence in the system.

•   Extensive and repeated field testing will be necessary for a detection system.

•   It is important to involve the end user (public health) in system development and testing.

•   The Department of Homeland Security (DHS) was encouraged to look beyond the familiar technologies and development pathways.


In the first of the four sessions, Raymond Mariella, Jr., a senior scientist at Lawrence Livermore National Laboratory (LLNL), provided an overview of his commissioned paper reviewing the state-of-the-art technologies available for detecting organisms using nucleic acid signatures (see Appendix G). The following topics were then discussed by the panelists: lessons that could be learned from other industries in autonomous detection and how those lessons might apply to BioWatch; the evolution of assays to include and exclude various threats; the current state-of-theart system used by the U.S. Postal Service (USPS) and next-generation autonomous detection system based on multiplex polymerase chain reaction (PCR) assays; and systems concepts and integration issues.

Nucleic-Acid Signatures at Three Levels of Readiness

In his interpretation of the three tiers of readiness, Mariella said that any system that would be deployable at TRL 6-plus by 2016 would have

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