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Ebola hemorrhagic virus, as the disease is officially known, causes massive hemorrhaging in its victims, ultimately resulting in organ failure and, 90 percent of the time, death. There is no treatment for the highly contagious virus, which lies mostly dormant in West Africa, popping up every few years, said Corgenix chief executive Doug Simpson.
Corgenix (OTC BB:CONX) is developing a rapid test to diagnose Ebola but is stalled because of a lack of funding for its work, Simpson said.
Typically, when patients are suspected of having Ebola, their blood samples must be sent as far away as Europe for testing, as facilities with proper testing capabilities are rare in West Africa. It can take a week or more for the results to come back, by which time the virus has spread and the patient may have died.
The rapid test being developed by Corgenix can diagnose Ebola in as little as 15 minutes, Simpson said, so patients can be quarantined immediately, a key step in preventing the disease from spreading. The test itself is simple: A small sample of blood is applied to a thin, two-inch long white strip. Similar to a pregnancy test, the results display either positive or negative after about 15 minutes.
Outbreaks of Ebola usually occur when someone eats an infected fruit bat or other animal carrying the disease, which then spreads quickly through human populations via contact with someone who is infected, making quarantine essential to controlling the spread of the virus.
The most recent outbreak of Ebola, which began March 25, has killed more than 115 people. The disease has a 90 percent mortality rate, according to the federal Centers for Disease Control and Prevention. The last time this strain of Ebola broke out was in 2009, according to the CDC.
The rapid testing method being developed by Corgenix can help control outbreaks at the outset, Simpson said. Because Ebola only breaks out every few years, it can be difficult to contain because health-care workers usually assume that patients exhibiting symptoms have the much more common malaria and treat for that, which does not require quarantine.
After malaria, the next most common disease with the same symptoms is Lassa fever, for which Corgenix also produces a rapid test. Lassa can be cured using a cocktail of dangerous but effective drugs, Simpson said.
After receiving a $600,000 grant in 2010 from the National Institutes of Health, Corgenix was able to adapt its Lassa fever test to Ebola, but the grant ran out before the test could get through the necessary regulatory testing, Simpson said. The company has since applied for other grant funding to finish the work, but as yet has had no luck obtaining more money.
Corgenix must test its products on dead strains of the virus, since it does not have high enough security clearance to handle live strains of Ebola. Facilities must be rated Biosecurity Level 4 to handle live strains of Ebola. Only 15 of these facilities exist nationwide, and none is in Colorado. Corgenix is a Biosecurity Level 2 facility.
The disease also is relegated to a small, oft-forgotten part of the world, but with the increased mobility of people and products it eventually could spread to more developed nations. What’s more, the U.S. government is worried that the virus could be weaponized, Simpson said.
Kathleen Sebelius, former U.S. secretary of health and human services, stressed increased globalization as a health concern in a recent speech at the University of Colorado-Boulder.
Actions and outbreaks in one part of the world have the potential to impact everyone, Sebelius said during remarks at the Conference on World Affairs earlier this month. Everyone is connected by food, water, air, trade and travel, she said.
“In this 21st-century world, we’re no longer separated by two oceans,” she said.
While tragic, every outbreak brings with it a new opportunity to bring Ebola to the forefront and obtain new grant funding.
“This outbreak reinforces the importance of developing and testing a rapid Ebola test,´ said Robert Garry, professor of microbiology and immunology at the Tulane University School of Medicine, in an email. “In patients demonstrating fevers, we need the ability to not only screen for Lassa, but also Ebola. The (Viral Hemorrhagic Fever Consortium) is expanding on our existing diagnostic testing foundation to advance Ebola testing in the same way we’ve been successful with the development of the rapid test for the Lassa virus.”
The Viral Hemorrhagic Fever Consortium is an international group that is working to win approval for rapid tests for Ebola and Lassa, among other diseases. Nine organizations in addition to Corgenix are involved. Last month, the consortium sent experts to Guinea to help deal with the Ebola outbreak.
In Africa, the European Medicines Agency standards are used to determine whether a product is ready to be commercialized, rather than standards set forth by the U.S. Food and Drug Administration, Simpson said. The Lassa fever test produced by Corgenix is approved by the European Medicines Agency, but the Ebola test has yet to be approved, he said.
Ebola, while gory and deadly, isn’t a top-of-mind disease in a world where conditions such as HIV and cancer still are incurable. Finding grant money to research ways to keep the disease under control is hard, Simpson said, but his company isn’t giving up.
Although the going is slow, Simpson is sure the tests eventually will be approved and made available to those who need them.
“It is so rare, but when it pops up, it’s ugly,” he said. “It’s going to come popping up again. We want to advance (rapid testing) to the stage where it can be used next time.”
Molly Armbrister can be reached at 970-232-3129 or firstname.lastname@example.org. Follow her on Twitter at @marmbristerBW.