Originally Published IVD Technology July/August 2002
IN PERSON
Uncharted territory
A new consortium aims to create standards for biodefense technology.
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Howard Coleman is the chairman and CEO of Genelex Corp. (Redmond, WA). He can be reached via e-mail at howardc@genelex.com. |
A surge of biodefense technology development occurred in the months following September 11, 2001, leaving public officials with an exceptionally high number of new technologies to choose from and surprisingly few standards to differentiate the technologies' capabilities. In an effort to spur dialogue among technology users, manufacturers, suppliers, and regulators about developing standards, Howard Coleman, chairman and CEO of Genelex Corp. (Redmond, WA), is spearheading an effort to form the Homeland Defense Technology Council (HDTC). Any organization, company, government agency, or individual with an interest in promoting homeland defense is eligible for membership in the HDTC.
In this interview with IVD Technology editor Steve Halasey, Coleman describes how the HDTC will bring both private and public officials together to formulate reliable, relevant standards for biodefense technology. For the complete text of this interview, visit the IVD Technology Web site at http://www.devicelink.com/ivdt.
IVD Technology: How did you come to form the Homeland Defense Technology Council (HDTC)?
Howard Coleman: In 1987, I founded Genelex Corp., one of the first private-sector forensic DNA testing laboratories and, through the early 1990s, participated in the DNA wars over the acceptance of DNA identity testing in criminal trials. During that period, the human-identity testing industry dealt with many of the issues that homeland defense technology developers and sellers are now confronting. Both cases are examples of the private-technology sector bringing new technologies to the public-sector consumer.
In 1993, Genelex was one of the founding companies of a human identity trade association that turned out to be very helpful in allowing the private sector to contribute more fully to the standards-setting process.
While hosting a session on equipment and standardization at the Biodefense Mobilization Conference (Seattle) this April, I realized that the issues under discussion were very similar to the issues we dealt with in the early days of forensic DNA testing. Key issues surrounding this process are those of quality, standardization, and regulation, all of which require open and active communication to resolve. So I gathered a group of homeland defense technologists together to form the HDTC.
Biological Detection
What issues do you forsee being the most pressing for the HDTC?
Field biological detection is an area of intense interest now and presents a difficult problem because of the gap that exists between public and responder expectations and the actual capabilities of currently available technologies.
Educating the public and responders about technology development is an important function that the HDTC can play, and that will help bring peoples' expectations of testing systems more in line with reality.
Are companies that usually provide point-of-care diagnostic products primarily involved in the handheld first-responder units?
Many of the currently available biodetectors draw on antibody-based and other techniques widely used in diagnostics. Response Biomedical Corp. (Burnaby, BC, Canada), for example, has a point-of-care device that has been adapted to detect B. anthracis. A user applies the specimen to the test strip, inserts it in the reader, and has a reliable result in 10 or 15 minutes. A similar system, developed specifically for first responders and in widespread use, is made in partnership by Alexeter Technologies (Wheeling, IL) and Tetracore (Gaithersburg, MD).
So there is really not just a single technology involved, but levels of technology that are used at different times for different purposes?
Absolutely. There are myriad technologies that have been or are being developed. These include air-sampling technologies less related to diagnostics, like the MesoSystems Technologies (Albuquerque) portable air sampler and a high-capacity device under development by InnovaTek (Richland, WA), with funding from government agencies, such as the Defense Advanced Research Projects Agency (DARPA; Arlington, VA).
Working with Government
I understand that many government authorities and responding agencies attended
the Biodefense Mobilization Conference in April. What was discussed there about
the kind of requirements they would like to have put forth?
The interagency advisory board on equipment standardization and interoperability (IAB) is sponsored by the FBI, the Federal Emergency Management Agency (FEMA), and the military, and is composed primarily of first responders. An important part of their charter is to encourage and work toward establishing realistic and usable minimum performance standards for first-responder equipment. This can involve a bewildering variety of agencies. As you can imagine, standards for the varieties of equipment under discussion run the gamut from fully implemented equipment to nonexistent equipment.
Events at a recent meeting of the IAB in conjunction with the National Defense Industrial Association in Los Angeles illustrate how the HDTC can help in this process. The Centers for Disease Control and Prevention (CDC; Atlanta) and the Office of Public Health Preparedness are taking a policy stance that none of the existing biodetection systems should be used in the field, and that all testing should be performed in their nationwide network of laboratories. From the perspective of making treatment decisions, this makes sense. From the perspective of the first responder having to deal with a pile of white powder on the sidewalk, it does not make sense.
Consider the consequences of waiting a few days to decide what to do when that pile of white powder is in a school or office.
What actions are you taking in response to CDC's possible policy stance?
To help clarify this situation, the HDTC is preparing a white paper. The purpose of the white paper will be to help define the appropriate circumstances under which certain technologies can be used, and to define the specifications of the technology—sensitivity, specificity, interference, and cross-reactivity—that must be known before results can be interpreted. Many of the problems associated with currently available biodetectors result from lack of training and experience. Instead of throwing these devices out, we need to come up to speed as to their proper use. Part of that process will be to help promulgate the appropriate quality standards.
Forming Standards
What are the intentions of the people in the Office of Homeland Security?
Have they expressed any interest in this issue? Are they aware of what is going
on in the field?
So far we haven't heard from the Office of Homeland Security, but Jim Whelan, CEO of Alexeter Technologies, was asked to present his views at a recent meeting of the U.S. Department of Health and Human Services (Washington, DC) Council on Private Sector Initiatives to Improve the Security, Safety, and Quality of Health Care. The clear message he expressed was that the private sector could greatly accelerate the adoption of standards in this area.
Bill Radvak, CEO of Response Biomedical, was asked to present at a recent meeting of the Food and Drug Law Institute (FDLI; Washington, DC). He called on FDA to become involved in regulating biological tests to protect first responders by ensuring that manufacturers were meeting their claims.
It seems that there are a lot of different types of groups that could have a stake in this. Will the diversity of membership allow you to draw on the members' support to advance the standards-writing process?
Yes. The June IAB meeting in Los Angeles was key for us. The chair of the meeting was A. D. Vickery, who is the special operations fire chief in Seattle. He has encouraged our organization because we are a group, not an individual company. That is the value of starting a technology council.
I want to avoid calling it a trade association because we want to include public-sector participation. If public-sector organizations don't join, I'm going to advocate the appointment of public-sector officials to our board of directors, because keeping public and private people communicating with one another is extremely important.
One of the main missions of this organization and the Biodefense Mobilization Conferences that we're sponsoring is to bring these disparate groups together to exchange information and educate each other. Our April meeting was very successful in that regard.
My bottom-line goal is to get people talking to one another and to open things up for clearer communication. More-effective cooperation than we've seen in the past is essential to reaching the common goal of making our country a safer, more secure place.
Copyright ©2002 IVD Technology
