HOUSE ARMED SERVICES SUBCOMMITTEE ON
MILITARY RESEARCH AND DEVELOPMENT
Research and Development in Support of the War on Terrorism

February 21, 2002

Testimony presented by Randy White, Nanogen

The events of September 11^th certainly raised our awareness concerning terrorist capabilities and determination.  Although significant strides have been made to improve our preparedness, the nation is unprepared for rapid detection and diagnosis in the face of a biological attack.  The CDC (Center for Disease Control) is currently overwhelmed with activities connected to the most recent anthrax crisis.  Further, the potential devastation that certain biologic agents can cause in a 24-hour cycle is such that centralized testing facilities like the CDC, or even regionalized testing centers like Fort Dietrich are inadequate in response time.  In a true biologic attack, time is of the essence to prevent/minimize loss of life.  A recent article published in Emerging Infectious Diseases[1] showed a comparison of the effects of a 10-kiloton nuclear bomb and a 10-kilogram weapons grade anthrax release.  The report shows that the death rates would be essentially the same.   For this reason, detection and testing capabilities should be available in all major metropolitan centers to provide the quickest possible turnaround time so that proper emergency treatment and quarantine measures can be implemented if required, or the all clear sounded as quickly as possible if a false alarm.

Current DNA testing is a three-step process: extraction of genomic DNA from a sample source; an amplification step; and finally a detection system.  All of our DUST/DARPA funding has been directed toward developing a single-step portable sample-to-answer device.  However, Nanogen's current instrument is capable of detecting Anthrax, Smallpox, Yersinia pestis, Botulinum toxin and many other pathogens using the three-step process.  This is true not only with the Nanogen system, but with other current technologies as well.  Thus, my first recommendation is to fund establishment of testing/detection systems in every major metropolitan area and to link these systems via the Internet and/or through wireless communication devices to regional and central monitoring locations.  Nanogen has this capability today.

Historically, DUST and DARPA funding administrations have done an excellent job of identifying emerging technology.  Grants have specific timeframes, milestones and deliverables.  While funding in the several million dollar range has been available to develop prototypes, or proof-of-principal, no funding has been available to continue the development of the prototype into a commercial instrument.  This is a required prerequisite to enter the government-contracting arena for deployment of fully functional sample-to-answer devices.  Thus, my second recommendation is that DUST/DARPA begin an immediate review of sample-to-answer prototypes that have been produced by a variety of biotechnology companies over the last three years.  Adequate funding should then be made available to further develop to a near commercial level those prototypes deemed to have the best potential for use in biowarfare.

In summary, the San Diego biotechnology community and indeed the nation's biotechnology community stands ready to answer the need for rapid detection and testing in the event of biological attack.  DUST and DARPA grants over the last several years have produced numerous prototypes of sample-to-answer devices.  The following are respectfully submitted as recommendations for increasing the nation's preparedness for biological attack:

• For each major metropolitan area, fund placement of existing technology platforms capable of detecting biological pathogens and provide emergency medical training required to handle a mass casualty event.
• Facilitate review of biowarfare sample-to-answer prototypes developed under DUST/DARPA grants over the last three years.  For those deemed to have the greatest potential use in combating biological attack, fund further development toward a commercial instrument