BOULDER, Colo. (AP) — When an Ebola virus outbreak occurred in West Africa last month, officials for Broomfield-based Corgenix Medical Corp. scrambled and raided their local laboratory coolers to assemble a potential line of defense: prototype tests developed to detect the deadly virus in a matter of minutes.
At least 70 people have reportedly died in south Guinea since the outbreak started two weeks ago.
Amid heightened concerns that the deadly virus may spread and affect people in neighboring Liberia and Sierra Leone — where scientists are researching and conducting tests for Corgenix and the global Viral Hemorrhagic Fever Consortium — Corgenix shipped the entire stock of its prototype tests to Africa.
"We have to set up sort of a front line of defense in Sierra Leone," said Corgenix president and CEO Douglass Simpson. "We also are getting a lot of interesting requests (from other research teams and agencies) screaming for the product. Everyone over there is literally scared to death.
"It just spreads like wildfire and then it goes quiet."
Ebola outbreaks have a case fatality rate of up to 90 percent, according to the World Health Organization. The virus is fast-spreading and can kill an infected person in a matter of days or weeks.
There is no vaccine or specific treatment for Ebola. Some potential therapies are being evaluated.
Corgenix, founded in 1990, develops diagnostic products that range from tests to determine aspirin's effectiveness in individual humans to assays that can rapidly detect viral hemorrhagic fever.
Sitting on the sidelines of that cache of 50-plus products was the Ebola test, which resulted from a 2010-2012 research program conducted with the Viral Hemorrhagic Fever Consortium and funded with nearly $600,000 from the National Institutes of Health.
The Ebola assay has identified potential indications of Ebola virus in 15 minutes after an initial screen and confirmed the diagnosis in an "hour and change," Simpson said.
That test, however, has not been cleared or approved for diagnostic use by any worldwide agency.
"We couldn't get any more funding for it," Simpson said. "The funding ran out, but we actually developed programs that worked."
Since the National Institutes of Health study concluded, work related to the Ebola assay have been relegated to limited laboratory testing at Corgenix's facility in Broomfield and in consortium partner facilities such as the Scripps Research Institute in La Jolla, Calif., and the University of Texas Medical Branch in Galveston. The tests do not involve any live samples of the virus.
Corgenix needed additional funding to conduct tests in the field, but the company's follow-up proposal for an additional research grant was not approved, he said. A reason for the denial was not provided, but Simpson said he knows there are limitations in research funding and that there are needs to address more immediate and endemic diseases and viruses.
Current testing procedures for Ebola involve sending blood samples to a laboratory in France, where "the highest level of testing possible" occurs, Simpson said.
Simpson estimated that it would take about $1 million and two to three years to bring the Ebola product to where Corgenix's Lassa fever test is now.
ReLASV last year received CE Mark approval, which allows for the product's sale and diagnostic use in the European Union and other international markets.