Imagine a scenario in which, instead of waiting 24 hours to hear back from a lab about possible exposure to bioweapons, you could get an answer in minutes. The test wouldn't just be for exposure to anthrax, either. It would encompass several deadly pathogens simultaneously. Now suppose the entire procedure took place on a personal computerlike device small enough to be carted onto a battlefield, or to government buildings, post offices, or schools.
This diagnostic utopia is the shared dream of a number of small companies that have recently been thrust into the spotlight. On Oct. 12, IGEN International Inc. (IGEN) of Gaithersburg, Md., announced that it would step up its joint research with the U.S. Army to develop systems that can quickly detect toxins in food, air, and water. Two California companies working on DNA-based tests, Cepheid (CPHD) and Nanogen Inc. (NGEN), are also being backed by the military. Others that have demonstrated rapid diagnostic systems--such as Idaho Technology and Bruker Daltonics Inc. (BDAL)--are also refining their germ-warfare wares.
FINDING ALTERED GERMS. None of these companies has a device that can address all of America's diagnostic needs. But experts in this area are confident that within a year or two, doctors around the U.S. could start to get their hands on a generation of tools that will provide faster, sharper portraits of disease threats facing the nation. "The vision is to create something like a smoke detector or handheld computer that you can send out into the field," says Steven E. Koonin, a professor at the California Institute of Technology and an adviser to the U.S. Defense Dept. "There is a great need for that."
The approaches to diagnostics are as varied as the individual players. IGEN's technology uses chemicals and light to analyze DNA, proteins, and other biological material bearing the characteristic marks of specific pathogens. Cepheid's systems use a chemical method that amplifies DNA, so trace levels of biological agents can be detected. Nanogen employs a chip that uses electrical charges to help analyze genetic material. The hope is not only to pinpoint disease-causing agents but also to identify germs that have been altered, say, to resist certain antibiotics.
Some of the most exotic devices have attracted serious interest in military circles. Bruker Daltonics, for example, uses a chemical-analysis process known as mass spectrometry to identify biological agents in the air in as little as three minutes. Right now, the equipment fills a Humvee, and the bill for just one system runs about $250,000. Still, on Sept 18, the U.S. Army announced a $10 million order for Bruker's analyzers.
Cepheid, IGEN, and Nanogen have also targeted the military as an important test market for top-of-the-line diagnostic systems that are fast and portable. While those systems are under development, all three companies have begun selling larger, slower versions to drug and biotech companies and various private labs. Nanogen, for example, has sold seven of its $160,000 systems in the third quarter alone, plus reagents and other materials--leading analysts to predict that the company will bring in $13 million in revenues this year, up from $11 million last year.
Some of the diagnostic prototypes have a Star Trek feel and may not be available as practical tools for several years. Cyrano Sciences Inc. is selling an artificial nose that can sniff out certain microbes and may someday help detect bioweapons. A scientific team at the University of Texas at Austin has an artificial tongue that changes color when exposed to various toxins. "The fundamental problem is that the number of molecules is extremely small, so you'd have to suck a cubic meter of air through something and catch every particle in there," says Dr. Dean Neikirk, a member of the artificial tongue team. "That's certainly a challenge," he says. But as the ripples of bioterror grow more sinister, even far-out solutions are to be encouraged. By Arlene Weintraub in Los Angeles and Alex Salkever in New York