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Medical Devices / Regulatory Affairs / Research and Development / Commercial Operations

Corgenix Medical Rushes Development of Rapid Ebola Diagnostic

March 31, 2014
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A recent outbreak of Ebola hemorrhagic fever believed to have originated in the West African country of Guinea has “thrown [Corgenix Medical] a curveball,” said President and CEO Douglass Simpson, spurring the Broomfield, Colo. diagnostics maker to bring its prototype rapid Ebola assay to Sierra Leone.

Corgenix’s test is the first rapid Ebola assay in existence, Simpson told Device Daily Bulletin. Since laboratories in West Africa are not capable of supporting the special laboratory features and polymerase chain reaction equipment required to run Ebola tests, samples suspected of harboring Ebola have been sent to countries such as France for testing.

The problem with that, Simpson said, is that such testing can take a week and, by that point, an Ebola patient may very well be dead. By contrast, Corgenix’s Ebola assay can return results in under an hour, allowing physicians to quickly diagnose the virus and prepare some kind of treatment, he said.

In 2010, the National Institutes of Health awarded Corgenix, Tulane University, the Scripps Research Institute and Autoimmune Technologies a grant to develop rapid diagnostics for Ebola and for the Marburg virus, another hemorrhagic fever disease.

The Ebola test is not officially approved for use in any country. With the NIH funding, Corgenix developed a rapid assay for both viruses, but the grant ran out and the assays sat on the shelf, unable to gather enough clinical samples to support regulatory filings, Simpson explained.

The use of the Ebola assay to diagnose patients infected during the current outbreak, and the data that could generate, could advance Corgenix’s assays, but “right now, we have to respond” to the crisis in Sierra Leone, Simpson stressed. A team is currently headed to the country.

The devicemaker’s ReLASV Lassa fever assay has CE Mark approval, Simpson noted, adding that many West African countries where Lassa is common accept the CE Mark and are using the test. — Lena Freund

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