The biodefense industry has reached a critical point in its evolution. To accelerate product development for biodefense-related diagnostics, therapeutics, and reagents, we urgently need biological consensus standards - which generally do not exist. These standards can have an impact on overall R&D productivity and quality as profound as any technological advance, a fact readily acknowledged by biodefense leaders.

Within biodefense-related R&D, standard biological materials and processes are critical in three general areas. First, standards help properly validate instruments and assays used in measuring, producing, or testing products for biodefense applications. For example, scientists need standard microorganisms to validate an instrument designed to identify threat agents from environmental samples in the field. Second, we need standard biodefense-related materials and protocols to train personnel and confirm the capabilities of a biodefense laboratory; standards are invaluable for evaluating an individual's or laboratory's performance at identifying or assaying particular bioagents. Third, standards help compare...

Special needs for end-user groups

The panel acknowledged that certain standards - such as transport - could be of general use, while others, such as limits of sensitivity and specificity, would be specific to different end-user groups. They acknowledged the reality that biodefense standards would be employed by different groups with potentially different needs, including groups involved with food and water testing, environmental surveillance, diagnostics, or forensics. As a result, standards must address the differences in needs for the various end-user communities.

Meeting materials, an attendee list, slides from the presentations, and notes from the discussion sessions are available online at the conference Web site: To move toward developing voluntary consensus standards, a wider group of stakeholders will be assembled to sustain momentum and maximize participant buy-in. In the next year, a series of follow-up conferences to the April expert panel gathering will be held in order to begin development of specific biodefense standards.

Scott Jenkins is a science writer at ATCC. Joseph Perrone is the vice president for standards and certification at ATCC and chaired the Expert Panel.

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