Medical Device Link.

Originally Published IVD Technology January/February 2004

COMMENTARY

Bruce J. Tedeschi

Bruce J. Tedeschi is chief executive officer at Collaborative Genetics Inc. (Rexburg, ID). He can be reached at btedeschi@collaborativegenetics.com

Biological pathogens have been used as weapons for centuries. Using pathogens for terrorist purposes started in the sixth century BC, when the Assyrians poisoned the wells of their enemies, and continues up to the present day. In November 2001, the Centers for Disease Control and Prevention (CDC; Atlanta) reported 21 anthrax cases from the now infamous anthrax letters incident. Throughout the course of history, scientists have become increasingly adept at refining biological pathogens to be more lethal and easier to disperse into the general public.

For example, the Soviet Union operated a biological weapons program from 1926 to 1992. During that time, the Soviet Union weaponized a number of biological agents such as smallpox, plague, tularemia, anthrax, typhus, and many others.¹ At one point, the Soviet Union had developed enough weaponized anthrax to kill practically every life form on the planet three times over.

The current public perception is that society only needs to be concerned about those pathogens that directly affect human beings. However, this perception is flawed. As demonstrated by the Soviet Union's former biological weapons program—and even similar efforts in the United States—rogue nations and terrorists too may have the ability to develop biological pathogens that also affect plants and animals.

Government Support

On November 3, 2001, on the heels of the September 11 tragedies and the ensuing anthrax contamination letters, Health and Human Services secretary Tommy Thompson voiced his concern about false-positive results from more-rapid biowarfare testing methods being developed at that time.² Thompson's statement had a negative impact on promising research being undertaken to develop better rapid-diagnostic tests.

Before the September 11 terrorist attacks, research on detecting biological warfare pathogens had been minimal. The events surrounding September 11 have forced many researchers to undergo crash courses to learn about the characteristics, pathology, and epidemiology of these very dangerous elements. One valuable source of information has been the Internet, which provides access to papers, articles, and reference materials on the subject. The Internet also offers information about current discoveries, other plans in development, and, most importantly, where grant and contract funding for biowarfare research is available.

Several government agencies, such as the Defense Advanced Research Projects Agency (DARPA; Arlington, VA), the National Institutes of Health (NIH; Bethesda, MD), and the CDC, have been overseeing the approval process for research grants and the distribution of grant money.

Since the terrorist attacks of September 11, the Bush administration and Congress have approved about $58 billion for homeland defense, antiterrorism, and recovery efforts. While the federal government provided $18 billion through the 2002 fiscal year appropriations bills, the remaining $40 billion was included in emergency supplemental appropriations.

The federal government reached this $18 billion figure after closely examining programs related to homeland defense and combating terrorism, and determining which it was particularly interested in supporting. According to the Center for Strategic and Budgetary Assessments (Washington, DC), $10 billion will be used for combating terrorism, including biodefense technologies against weapons of mass destruction; $2 billion to $3 billion for critical infrastructure protection; and $5 billion for other defense-related purposes.

With government assistance, the IVD industry has been making significant progress in building better diagnostics for biological weapons. Even though the process of preparing, submitting, and reviewing grant applications for research funding needs to be streamlined, researchers have made great strides.

Detecting Biological Pathogens

Many different types of detection technologies exist today. These technologies span the gamut from enzyme-linked immunosorbent assays to optical sensors and lasers. Prior to September 11, efforts to develop these technologies into better diagnostics for biological and chemical pathogens were minimal. Today, hundreds of individuals, organizations, researchers, and companies are focusing on building the next generation of innovative biodefense detection technologies.

The problem with many of the tests currently being developed is that they are limited to environmental sampling or testing. For example, one promising environmental diagnostic test is the bioaerosol mass spectrometry (BAMS) system by Lawrence Livermore National Laboratory (Livermore, CA). By combining laser and spectroscopy technologies, this portable system can provide detection down to one spore in 300 milliseconds. However, this device is not yet on the market, despite field-testing performed in Florida that yielded 100% specificity and accuracy for detecting pathogens.

Comparatively little has been done to advance reliable, rapid-detection methods for these disease pathogens in human blood. While morbidity from inhalational anthrax may ensue within a matter of days, the prevailing standard for testing human fluids is still primarily performed using a blood/agar plating system that is very labor intensive and takes 12–36 hours to get reliable results in a laboratory setting. This form of testing cannot be run in the field.

With this in mind, several companies have been working on developing one-step, rapid-result, DNA-based handheld field devices. For example, Collaborative Genetics Inc. (Rexburg, ID) and IIT Research Institute (Chicago) are collaborating in developing a one-step in-the-field device that would provide better diagnostic capabilities for the military and first responders.

Understanding Biological Warfare Pathogens

One of the critical factors in developing better biodefense diagnostics is understanding the pathogens and how they become weaponized. One example is Bacillus anthracis, the species of anthrax that is known as inhalational anthrax. Bacillus anthracis naturally occurs in soil, diseased animal carcasses, and other elements. However, bioterrorists have not weaponized naturally occurring anthrax spores because their generally 5-µm spore size is filtered out by the body's nasal hairs, thus preventing them from moving further into the pulmonary system.

Weaponized anthrax is engineered by terrorists to be 1–3 µm in size and so void of moisture that the spores readily float in the air. Because of the lack of moisture and its lighter weight, weaponized anthrax is easily dispersed and can be carried by wind currents. Other pathogens that are viral in nature can be weaponized in a similar fashion or can be dispersed by means such as a crop duster.

Lack of Facilities

Today, there are fewer than 10 biosafety level (BSL)-4 labs in the United States. These labs house some of the most dangerous pathogens known to man, ones that could decimate all living creatures on Earth. Yet, these labs are needed to conduct further research for homeland defense. Far more BSL-3 labs exist. However, due to the lack of facilities and the high demand on present BSL-3 labs, the research community does not have adequate access to such labs to conduct research on some of the most troublesome pathogens that may be used. In addition, in rural areas there are only one or two BSL-3 labs. The major factors hampering the opening of more of these labs are lack of capital investment, regulations, opposition by some misinformed alarmist environmental watch groups, and an uncertain market. The turnkey cost to open a BSL-3 lab can run $1 million per 1000 square feet.

Conclusion

The IVD industry has made significant progress during the two years since September 11 in developing tests for biological and chemical weapon detection. History has taught us that IVD manufacturers must continue to make strides by improving technologies used for detecting biowarfare agents. The industry has the capacity and the tools to develop the world's best biodefense technologies against bioterrorist threats. While environmental testing methods have made the greatest advancements, the promise of rapid, reliable, one-step diagnostics for detection of pathogens in human fluids is on the horizon.

To continue making the needed advancements in all forms of biowarfare diagnostics, manufacturers must deliver a strong message to legislatures, venture capital firms, and others to secure the funding, facilities, and minds needed to protect the United States. The IVD industry needs to contact state and federal legislators and voice its concern about the urgent need for advanced diagnostic products. Researchers still encounter delays in receiving the funding necessary to start, continue, or complete all aspects of their research on biological defense. IVD manufacturers must lobby legislators to reduce the red tape required to receive grant or contract funding.

References

1. M Leitenberg, "Biological Weapons in the Twentieth Century: A Review and Analysis," International Symposium on Protection Against Chemical and Biological Warfare (2001) [accessed 5 November 2003; available from Internet: www.fas.org/bwc/papers/bw20th.htm].

2. S Borenstein, "Bio-Terrorism: Quickie Anthrax Tests Are Unreliable, but the Better Method Can Take Up to Two Days," Detroit Free Press (2001) [accessed 5 November 2003; available from Internet: www.freep.com/news/nw/terror2001/test3_20011103.htm].

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