Roche Ebola Test Authorized By FDA For Emergency Use
By Chuck Seegert, Ph.D.
Emergency use authorization has been granted to Roche by the FDA for its LightMix Ebola Zaire rRT-PCR Test. The test requires whole blood samples and is run on the manufacturer’s large LightCycler 480 or cobas z 480 laboratory-based instruments. Providing results in about three hours, LightMix is designed for patients exhibiting symptoms of Ebola Zaire that may have epidemiologic risk factors — like travel history in high-risk regions.
As the death toll from the West African Ebola outbreak continues to climb, efforts to combat the disease remain a top priority. As part of this response, Roche, a world leader in research-focused diagnostics, has obtained emergency use authorization (EUA) for its LightMix Ebola Zaire rRT-PCR test from the FDA, according to a recent press release. The new test is a single-tube duplex assay that employs whole blood and qualitatively detects the Ebola Zaire virus. In addition to this virus, which is the primary strain involved in the outbreak, the diagnostic tool detects a human housekeeping gene as an internal control.
The test is designed to be run on Roche’s LightCycler 480 or cobas z 480, which are both large laboratory-based units designed for high throughput diagnostics, according to the press release. Including sample preparation, these platforms can run up to 96 samples per batch in just over 3 hours. As part of the requirements of the EUA, the test must be run in Clinical Laboratory Improvement Amendments certified laboratories in the United States, or similarly qualified non-U.S. laboratories.
The test is only authorized for diagnosing the Ebola Zaire virus, and the EUA is limited to the duration of circumstances that justify the emergency use of the diagnostic. The test is still not cleared by the FDA, and the EUA can be terminated or revoked. However, the test has received a CE mark and is available in markets that recognize and accept this certification.
The dire nature of the Ebola threat is reinforced by recent estimates from the Centers for Disease Control, which show that the epidemic has reached a total of 19,463 cases with as many as 7,573 deaths.
The EUA granted to Roche is not the first emergency authorization issued by the FDA since the beginning of the epidemic. In fact, an Ebola diagnostic developed by the Department of Defense was authorized for emergency use by the agency in August of 2014. That test was also an RT-PCR assay using whole blood, according to a recent story on Med Device Online.
While the RT-PCR tests are effective and have made significant progress in diagnosing the disease, faster options are being developed for point-of-care use that require only a drop or two of blood. One of these, being developed in France, is used in a way that is analogous to a home pregnancy test, providing results in as little as 15 minutes. Another from MIT is based on a paper test strip technology.