A Colorado company is developing a test for Ebola that could dramatically reduce the amount of time it takes to diagnose cases. Current tests can take hours -- even days -- to provide results, including the problem of simply shipping samples to laboratories. But Coregenix Medical Corp. in Broomfield hopes to introduce a rapid test where a drop of blood put on a test strip would provide a positive or negative result within 10 minutes.
“It’s simpler, quicker, cheaper, involves less training, and can be easily deployed in the field,” says Coregenix President and CEO Douglass Simpson.
A rapid test could be a boon to medical workers, who find it difficult to diagnose Ebola early. That's because the first stages of the virus mimic the symptoms of other maladies, such as malaria, typhoid fever -- even the flu.
Worldwide, there are 8,998 confirmed cases, as of Oct. 18, the most recent results available. There have also been 4,493 Ebola deaths, including one in the United States. Three cases have been confirmed in the United States, according to the U.S. Centers for Disease Control.
Currently, testing for Ebola requires time and expensive equipment. Both are in short supply in many of the affected regions in West Africa. By the time a sample of blood is shipped to a laboratory for testing, critical days can have passed, meaning infected patients aren't getting medical attention as quickly as needed, according to Simpson. Such patients can also pose a risk to the public because they can unwittingly spread the virus.
Patients will need to be symptomatic for the Coregenix test to work, Simpson says. Patients can begin displaying symptoms between two and 21 days of being infected, according to the World Health Organization.
The company started work on its test in 2010 with a grant from the National Institutes of Health, but had to table research when subsequent funding requests were denied.
“Their critique was we had no market to commercialize an Ebola test,” Simpson says.
The company reapplied, and in June of this year -- against the backdrop of the outbreak in West Africa -- the NIH awarded Coregenix $2.9 million to continue its work. Anyone looking for an immediate result will be disappointed: the three-year research project is not expected to yield an approved test any time soon.
"Even though the original timeline was for three years, which became the development plan approved and funded by the NIH, we have been in a fast-track mode for months and are making solid progress," Simpson says. "Based on the amount of data we must complete its not possible to predict with any certainty when it will all be completed, submitted to the various regulatory agencies, and ultimately, we hope, approved. Our goal is to get it done significantly earlier than originally planned."
The Coregenix facility in Broomfield does not house any live Ebola virus.
“There are only five labs in the U.S. that have the Ebola virus and we’re not one of them,” says Simpson. “We genetically engineer a protein exactly like the virus so that we can build diagnostic tests.”