ReEBOV may be one of the most important technologies developed by Corgenix Medical Corp., but it's not a financial boon for the 25-year-old diagnostic test firm.
Company officials would just as soon keep it that way.
ReEBOV this year became the first rapid diagnostic test to gain U.S. and international approval for use to detect the deadly Ebola virus.
In the past couple of weeks, more than 10,000 of the kits — which bear similarity to pregnancy tests and can detect the presence of Ebola in blood in less than 15 minutes, instead of hours or days — were shipped to clinics and hospitals across the globe.
"It would be highly unlikely that this product would ever be an enormous commercial success," said Douglass Simpson, the former Corgenix chief executive who now oversees the Broomfield firm's infectious-diseases group. "Certainly, we would hope not."
Since last summer, Ebola, which has no known cure or vaccine, has killed more than 11,000 people, mostly in West Africa, according to the Centers for Disease Control and Prevention.
But the worst-ever outbreak is waning, and that has Corgenix and other Colorado researchers racing to test their products before the disease goes dormant again.
Their aim: to develop an artillery of therapies and technologies along with a robust, data-driven network to track and combat Ebola the next time it rears its head. (Some countries, including Liberia, have been declared Ebola-free.)
"You can imagine that even before (the Ebola outbreak) that the health care infrastructure there needed some upgrading," said Asher Greenberg, Ebola project coordinator and communications officer for Fio Corp., a mobile diagnostics firm based in Canada. "The crisis has brought out a number of companies with solutions, but all of this needs to be integrated."
Corgenix's work, funded mostly by grants, includes adapting its ReEBOV test to be compatible with Fio's Deki Reader. The reader is an 8-inch-by-4-inch mobile device that analyzes and transmits data from immunoassay tests, like ReEBOV, that have been fit into a plastic housing about the size of a microcassette tape.
Researchers from Fio and Corgenix are in West Africa now, testing the new products in the lab and the field.
"This is a great time, with all of the attention still on West Africa, to update the infrastructure so that the next outbreak can be handled with less loss of life," Greenberg said.
Although the Ebola epidemic was thousands of miles away from the U.S., its severity spurred agencies such as the National Institutes of Health and organizations including the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation to pour billions of dollars into the fight.
Several million dollars went to Corgenix, a 55-employee company that has developed a cache of more than 50 diagnostic products spanning a variety of diseases.
Financial backing
Corgenix, in partnership with the Viral Hemorrhagic Fever Consortium, had success in bringing to market a rapid diagnostic test for Lassa, another deadly hemorrhagic fever, and dipped its toes in developing a similar test for Ebola.
When the latest Ebola outbreak worsened, Corgenix's Ebola research was brought to the frontline.
The Gates and Allen foundations both provided financial backing to integrate the Corgenix and Fio technologies. The aim not only was to identify and then isolate Ebola-infected individuals but also to gather data that would allow health officials to monitor potential hot spots and get a leg up on containment.
Matt Boisen, Corgenix's program director for infectious disease and emerging technologies, last week began his ninth research trip to West Africa. Before the Ebola outbreak, Boisen conducted research in Kenema, Sierra Leone, related to Corgenix's Lassa rapid test.
Boisen and other Corgenix employees and consortium research partners volunteered for the work, said Simpson, who moved from the role of CEO to consultant after Corgenix's acquisition last year by Orgentec.
"Thank goodness for people who are willing to go," said Simpson, who also has traveled to the region on behalf of Corgenix. "I don't think anyone is not fully aware of the dangers. If something were to happen, I'd carry that. I'd blame myself forever."
There are elements of risk in traveling to countries roiled by political unrest and to regions battling deadly diseases with limited health infrastructure. Despite a strict regimen of taking medications and applying skin protection from mosquitoes, Boisen returned from one of his trips and landed in a hospital with a case of malaria, said his wife, Shelly.
"He did go to Nigeria one time, and Matt and (other researchers) were escorted by several men with AK-47s," she said. "The whole time, all I'm thinking of is 'Are you safe? Are you safe? Are you safe?' "
On his trip earlier this year, Boisen saw how Ebola's spread overwhelmed the Kenema Government Hospital, effectively shutting it down temporarily.
Ebola killed several of his friends and associates at the Kenema hospital and lab.
"But that's why we take the precautions that we do," he said.
Boisen's work in Kenema will be centered entirely in the Lassa Fever Laboratory at the Kenema hospital, and any samples tested will take place under a protective hood.
Boisen will be wearing protective gear as he works, which helps lift some of the emotional weight that builds when he travels to hot zones, his wife of 14 years said.
"I know he's safe," said Shelly Boisen, who works as a certified nursing assistant at Longmont United Hospital. "He actually did a video for us the last time he went down. I'm going to give it to our hospital (as an example of) precaution training. It took him about 20 minutes to put on the first layer; he duct-tapes the shirt, puts on gloves, duct-tapes the gloves onto the sleeves, and puts on the helmet."
She's also buoyed by the understanding that the dangerous work being done by her husband and others is for the greater good.
"There are good people over there that are also helping and putting their lives on the line, and he's just one of them," she said. "He's done a lot of this in the company, too, in the lab — test after test after test after test to perfect it."
Complementing the on-the-ground work in Africa by Corgenix, Fio and others is Ebola-related domestic research such as that occurring at Colorado State University.
Grants for research
Mathematics professor Michael Kirby and the university's Biopharmaceutical Manufacturing and Academic Resource Center, or BioMARC, each received grants to conduct Ebola-related research.
BioMARC was awarded a $2 million subcontract from the U.S. Department of Defense in October to develop and manufacture a vaccine to protect against filoviruses, including Ebola and Marburg.
"The project is moving forward with successes that are in-line with product expectations," Dennis Pierro, BioMARC director, said in a statement. "We are advancing the product toward the objective of the U.S. Department of Defense."
BioMARC officials said they expect to provide more information in the coming months.
The separate mathematics-focused study has generated some positive initial results, said Kirby, a professor in CSU's departments of Computer Science and Mathematics.
Kirby previously applied mathematical algorithms to data collected from patients infected with the H1N1 influenza virus to try to understand how the flu virus moved through and took root in the immune system.
Analyzing the behavior of the more than 1,400 genes involved, Kirby helped to show the genetic pathway of the virus and identify the point at which an affected person became symptomatic.
"What we discover with influenza we hope will carry over to the Ebola virus," Kirby said.
Kirby's team does not collect the data but rather uses data sets that already are in the public domain, including that of infected mice and nonhuman primates.
The early results from the mice data showed some pathways that were comparable to human influenza infection.
"For Ebola, it's very interesting," he said. "There are no tests for Ebola until you've become symptomatic."
And it can be weeks after infection before symptoms such as a fever start to show.
Finding those pathways could bolster diagnostic and early warning tests and, ideally, limit the spread of the disease, he said.
"It's kind of like a canary in a coal mine," he said.
SOURCE: The Denver Post