The reason nobody's using it?
Nobody bought it.
Nancy McKinney, a former researcher at the laboratory, discovered a DNA marker unique to Bacillus anthracis, the bacterium that causes anthrax, that she says could enable sensors to pick out any strain of anthrax spore without being fooled by look-alikes. Because Lawrence Berkeley is a national laboratory, McKinney's work was funded by the U.S. Department of Energy and the Navy's Office of Naval Research. But McKinney says the politics of anti-bioterrorism research and a squabble over funding rights with another professor diverted attention from her discovery and led the military to invest in other, similar projects. Meanwhile, her patented biomarker has languished for two years on the lab's roster of technologies available for sale to bio-tech firms.
"It's just sitting here. If you wanted to license it, you could just write a check to the [University of California] Regents," says Lynn Yarris, a lab spokesperson. "You'd think that in two-plus years, something like this would attract attention. But no one here picked up that research, and no one's licensing the technology. Nobody has applied this."
McKinney declined to discuss on the record the "sordid tale" of her fight for funding but says politics and infighting have often held back anti-bioterrorism research.
"When we realized the value of this specific genomic marker for B. anthracis back in 1997, our attempts to tell the community of people working on anthrax and bioterrorism about our grand discovery met with every form of invalidation," she says. ""Who were these upstarts? What did they know, or more importantly, who did they know?' They never heard of us, we had a minuscule amount of funding, and we claimed to have the Holy Grail of anthrax detection markers? What has been going on in the anti-bioterrorism research community makes the politics in the HIV research community look like child's play. Remember, the bioterrorism community is composed of more than clinicians and research scientists -- the military and intelligence communities are included as well."
Most tests used by health officials and scientists identify anthrax by its telltale plasmids, circular pieces of extrachromosomal DNA that carry the genetic information that makes the bacterium so lethal. McKinney, however, looked beyond the obvious plasmids and found an even more specific gene sequence unique to anthrax. Conceivably, she says, a device patterned after a vacuum cleaner could collect air samples, filter the particles, and subject spores to chemical DNA probes looking to affix to anthrax-specific gene regions.
"I would love to be able to work on this, because I think it works," says McKinney, who left the Berkeley laboratory two years ago for the Centers for Disease Control in Atlanta and now works at a small Bay Area biotech firm. "There's recent work showing that DNA can act as an electrical circuit. If you have a piece of DNA that exists in one species but not in others, any completion of the circuit could be turned into something like an alarm. It isn't a kit yet, but it could be."
In addition, the technology is sensitive enough to not require a massive amount of spores in the air to detect anthrax, says Jennie Hunter-Cevera, a former colleague of McKinney's at Berkeley Lab who now heads the University of Maryland Biotechnology Institute. And because the biomarker is specific to anthrax -- not merely any bacillus spore -- tests could be fast and accurate, without the false alarms that plague other anthrax detection kits.
"It's a beautiful story, because everyone said it couldn't be done," Hunter-Cevera says. "It was grunt work. We logically, systematically looked at what genes had been associated with the spore, and No. 50 lit up. We filed for the patent, and it's been sitting on the Web ever since. It's just sitting there, and I'm surprised. I don't think Berkeley has been overly aggressive in pushing it."
But before Oct. 5, when a tabloid photo editor died of inhalation anthrax in Florida, private companies were not overly aggressive in purchasing the licenses for anthrax detection technologies.
Tetracore Inc. of Gaithersburg, Md., manufactures a commercially available antibody-based anthrax test, a hand-held strip that can identify anthrax within 15 minutes. Tetracore's president, Dr. William Nelson, says there is no instantaneous sensor capable of alerting a building to the presence of anthrax spores in the air. Until the Florida death and the recent spate of anthrax mailings to political and media offices, Nelson says, nobody even considered spending the kind of money on research to protect a broad spectrum of people or an entire room.
"If you said, "I want to protect my building,' I'd tell you, "There's nothing like a smoke detector that can do that, and don't let anybody say there is,'" says Nelson, who has worked with McKinney and Hunter-Cevera in developing technologies for the Navy. "There are people out there heading in that direction, but it would take a significant amount of work and an industrial partner. In the past, nobody would have wanted to put funds into it. Now everybody's working on it, because the world has changed, and what wasn't necessary is now necessary."
The military, however, has developed several anthrax detection models, including the highly sophisticated Portal Shield, a device capable of detecting eight biological agents. The Portal Shield consists of as many as 18 sensors, arrayed around an airfield or building, that can communicate, verify agents, and sound an alarm in unison.
Nelson says he thinks it will be five to 10 years before a private company develops a large-scale anthrax detection sensor, what he calls "generating a whole new thing."
Beyond the monetary concerns, such a kit would need approval from the Food and Drug Administration, which regulates the development of all medical devices that diagnose diseases. In addition, scientists would have to perform their research in an approved facility with access to virulent spores of various anthrax strains; not many biotech firms offer those capabilities, which the government fiercely limits and regulates.
Meanwhile, McKinney's patented biomarker has been available for years. Why hasn't anyone jumped at it? As Cheryl Fragiadakis, the head of Lawrence Berkeley Laboratory's technology transfer office, puts it: "We always find out why people go for things. We almost never find out why they don't."