FDA grants emergency use authorization to Corgenix's fast-acting Ebola diagnostic

"This thing isn't over yet," warned President Barack Obama's Ebola czar Ron Klain in a recent interview. While recovering slowly, West Africa is plagued by the epidemic and needs new tools in the ongoing battle against the disease.

To that end, the FDA just granted Emergency Use Authorization to Corgenix's Reebov Antigen Rapid Test for point-of-care diagnosis of Ebola in about 20 minutes, compared with days in the case of centralized laboratory testing. But the authorization is limited to "circumstances when use of a rapid Ebola test is determined to be more appropriate than use of an authorized Ebola nucleic acid (molecular) test, which has been demonstrated to be more sensitive in detecting the Ebola Zaire virus," according to the the release.

The World Health Organization says the protein-based test can identify 92% of Ebola victims and is 85% accurate in Ebola-negative patients. It is not intended for general use, such as screening at airports. Still, Corgenix says Ebola can have similar symptoms to other infectious diseases such as Dengue fever, Lassa fever, typhoid and malaria, making confirmatory testing critical.

Dr. Robert Garry

"Instead of taking days for lab results, the Ebola RDT uses a drop of blood from a finger prick to deliver a diagnosis in as little as 15 to 25 minutes, potentially allowing trained public health workers to isolate and treat patients immediately. Medical personnel will be able to quickly identify hotspots and may prevent resurgence of cases in the current outbreak," said Tulane University professor of microbiology and immunology Dr. Robert Garry, in a statement. He is also the principal investigator of the university's Viral Hemorrhagic Fever Consortium.

The FDA's action comes on the heels of the World Health Organization's decision to list the test as eligible for procurement to Ebola-affected countries. "While less accurate (than nucleic acid tests), 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. Where possible, results from Reebov antigen Rapid Test Kit should be confirmed by testing a new blood sample using an approved Ebola (nucleic acid test)," the agency said.

Meanwhile, last year Cepheid roped in $3.3 million in funding to roll out a new product that quickly scans for the virus and pinpoints areas where the disease is cropping up, and Roche ($RHHBY) snagged FDA approval for emergency use of its rapid Ebola test. In February, Johnson & Johnson's ($JNJ) Janssen Diagnostics said it is designing a product that runs on an automated molecular diagnostic platform and can complete an analysis in about 90 minutes.

All of these new Ebola developments share a common thread: They are designed to give rapid results.

- read the release
- here's the WHO decision
- here's the interview in Vox

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