Corgenix Medical and Fio Corp. Combine Rapid Ebola Test with Automated Analysis and Data Capture

Denver, Colo.-based Corgenix Medical Corp. and Toronto, Canada-based Fio Corp. have joined forces to integrate two technological advances to help end the Ebola outbreak in West Africa. The diagnostic device will be a rapid test, backed by the Bill & Melinda Gates Foundation and the Paul G. Allen Family Foundation, that can detect the virus in minutes. The system also will include a mobile device, which is being adapted with further funding from the Gates Foundation, to analyze and upload results directly to a central data system.

Fio is adapting its Deki Reader to work with the Corgenix ReEBOV Antigen Rapid Test for the Ebola virus, which recently received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) and was listed as eligible for procurement by the World Health Organization. According to the companies, combining the technologies will give suspected Ebola patients in the most remote, resource-poor settings, access to automated test results. Results will then immediately be transmitted to Fio’s data system, Fionet, capturing vital information that is currently missed or delayed.

“This collaboration makes testing more accessible to those at risk and data more readily available to those managing the outbreak, a combination that the Gates Foundation identified and mobilized,” said Michael M. Greenberg, chairman and CEO of Fio. “The resulting technology will expand the capability to fight Ebola now and strengthen national health systems beyond the current crisis.”

Corgenix researchers on the ground in Sierra Leone already have started using smartphones to transmit images of rapid Ebola test results to the Fionet data system. Together with Fio’s tools for case and contact mapping, this capability offers governments and other organizations responding to the outbreak a way to track the disease in real time.

“We’re taking the fight against Ebola to another level with Fio’s data collection and management, which is critical to the success of rapid testing,” said Douglass Simpson, Corgenix president and CEO. “This marks a tremendous advancement in Ebola testing, and it lays the groundwork for a strong and productive partnership between our two companies on future projects.”

The instant traceability of infected or potentially infected individuals—knowing test results, locations and movement over time and across borders—is essential to containing the spread of the Ebola virus and other highly contagious diseases.

Both companies will continue to work together to integrate the two technologies for decentralized Ebola virus testing throughout West Africa. Beyond the current crisis, this will serve health systems more broadly to better manage future outbreaks, as well as other infectious diseases in the region, such as Lassa virus.

Fio’s Deki Reader, which is already CE marked for use with rapid tests that detect malaria and dengue fever, is also being adapted for use with the Corgenix ReLASV Antigen Rapid Test for the Lassa virus.

Fio received a Gates Foundation grant in December 2014 to adapt its Deki Reader to analyze rapid Ebola tests and transmit results to Fionet to be integrated with case and contact management tools.

A few weeks later, Corgenix received two grants—one from the Gates Foundation and one from the Allen Family Foundation—to advance the company’s development of an Ebola rapid test kit.

Both the ReLASV Antigen Rapid Test and the ReEBOVT Antigen Rapid Test have not been cleared for routine diagnostic use by the FDA.

The ReLASV Antigen Rapid Test is CE-marked for diagnostic use in European Union and other countries that recognize the CE mark.

The ReEBOV Antigen Rapid Test is not CE marked and may only be used as a diagnostic device under the conditions of the Emergency Use Authorization issued by the FDA.

Fio’s technology, which is designed primarily for developing countries, connects mobile companion devices that guide diagnosis, treatment and record keeping with web-based tools for remote oversight and reporting.

Corgenix makes diagnostic kits for immunology disorders, vascular diseases, bone and joint disorders and a line of unique detection products for viral hemorrhagic disease. Additionally, Corgenix contract develops and manufactures products for key medical and life-science companies.