WHO Approves 15-Minute Ebola Test Developed by Corgenix

Xconomy Boulder/Denver — 

Doctors who continue to battle the Ebola epidemic that rages on in Africa—even if it’s once again out of the headlines in the U.S.—might be getting a new tool thanks to Corgenix, a medical test maker based outside Denver. On Thursday, the World Health Organization approved Corgenix’s blood test that can diagnose Ebola victims within 15 minutes.

Corgenix’s ReEBOV Antigen Rapid Test successfully identified Ebola in about 92 percent of people with the disease, and it was 85 percent effective at screening out people who were not infected, according to the WHO. That’s not as successful as conventional tests, but it is much faster. With the standard tests, doctors have to wait up to 24 hours before getting results from a laboratory.

The WHO said that was valuable enough to outweigh its comparative inaccuracy.

“While less accurate, the antigen test is rapid, easy to perform and does not require electricity—it can therefore be used at lower health care facilities or in mobile units for patients in remote settings,” the organization said in a release. It recommends that patients then undergo a standard test to confirm the result.

The test was evaluated under the organization’s Emergency Assessment and Use program, which was established to provide minimum quality, safety, and performance assurance for diagnostic products in the context of the Ebola emergency.

Standard Ebola tests search the virus’s genetic material, specifically nucleic acids. The Corgenix test searches for an Ebola protein.

A British virologist said the test “is not a gamechanger, but it is another useful tool.”

“The new test could help to quickly confirm outbreaks in remote areas without the need to send samples to a testing clinic and wait for results,” University of Reading virologist Ben Neuman said. “The new test isn’t about saving the lives of infected people, but it can help in the long run by making it easier and quicker to detect Ebola outbreaks.”

Corgenix (OTC: CONX) is located in Broomfield, CO, and before developing its Ebola test it focused on diagnostics for vascular and liver diseases. The company has received a number of grants to develop the Ebola test, including a $2.9 million grant from the National Institutes of Health and two grants totaling $818,000 from the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation.

The success of the new Ebola test comes despite some rocky times for the company. Early last year Corgenix announced it was looking for a buyer. It found one in Orgentec, a German company, which in August agreed to buy Corgenix for about $16 million. The deal was held up following a lawsuit from some Corgenix shareholders, but the suit has been dropped and the deal is expected to close this quarter.