Corgenix Gets FDA Clearance for Emergency Use of Its Ebola Test

The U.S. Food and Drug Administration (FDA) has granted emergency use authorization to Denver-based Corgenix for its rapid point-of-care assay for detecting Ebola. The FDA’s ruling permits Corgenix’s ReEBOV assay under those circumstances when use of a rapid Ebola test would be more appropriate than use of the currently authorized Ebola molecular test. That test may require a turnaround time of up to two days. The Corgenix test can confirm a diagnosis in 15 to 25 minutes. Late last year, Corgenix received $818,000 in grants from the Bill and Melinda Gates Foundation and the Paul G. Allen Family Foundation to help develop the assay for general clinical use. “The FDA and World Health Organization have been working closely with us throughout this process to get this new test in the hands of those battling on the front lines of the Ebola outbreak as quickly as possible,” said Corgenix Chief Executive Officer Douglass Simpson in a press release. “Completing this product development in less than a year demonstrates how governmental agencies, regulatory bodies, industry, non-profits and others can work together to find solutions to catastrophic events such as the Ebola virus outbreak. This collaboration has enabled us to quickly deliver this critically important point-of-care test and potential breakthrough in the fight against Ebola in the current outbreak in West Africa.” Although the Corgenix assay can be used in emergency situations, under the FDA rules it cannot be used for general screening such as at airports. The World Health Organization recently approved the test for field use outside of the United States. The first ever cases of Ebola in the United States were confirmed in the latter part of last year, initially linked to a Liberian national who traveled to Texas after already being infected in Africa. He died from the disease, and two health care workers who treated that patient were infected but later recovered. A New York physician who performed relief work in West Africa was also diagnosed with the disease after returning to the U.S. but recovered. There have been no cases in the U.S. this year, but large public health agencies such as the California Department of Public Health announced suspected cases of Ebola as recently as the end of January. And despite the handful of cases confirmed in the U.S., the Centers for Disease Control and Prevention performed close surveillance of more than 450 individuals who were in contact with those who contracted Ebola, suggesting that a rapid diagnostic test could have a market in the U.S. even if the number of confirmed cases within its borders are limited. Corgenix’s stock, which trades over-the-counter, dropped about 4 percent on the day of the announcement, to around 27 cents per share. Takeaway: Federal regulators have lent a helping hand in developing a rapid confirmation diagnostic for the Ebola virus.