U.S. health regulators have granted emergency authorization to a new Ebola virus test, a development that could help health care authorities battle the world's worst outbreak of the deadly disease, drugmaker Roche said Monday.
Patients with signs and symptoms of Ebola Zaire virus infection now have the approval of the U.S. Food and Drug Administration to use Roche's LightMix Ebola Zaire rRT-PCR Test in response to the rare disease, the Swiss company said in a statement. RT-PCR stands for reverse transcriptase polymerase chain reaction, Reuters reported.
The test, made by Berlin-based TIB MOLBIOL GmbH and distributed exclusively by Roche, would allow "health-care professionals to quickly detect the virus and start patient treatment as early as possible," said Roland Diggelman, chief operating officer at Roche's diagnostics division.
Since the LightMix test manages to generate results in about three hours, the virus can be detected extremely quickly, with doctors being able to start treatment as soon as possible, according to Forbes.
The LightMix's fast turnaround allows "healthcare professionals to quickly detect the virus and start patient treatment as early as possible," said Diggelman.
However, certain laboratories in the United States and other countries have been authorized to use the test only for a limited period to detect the type of Ebola strain that has been spreading in West Africa, according to the test's emergency use designation.
In addition, the emergency test, which can detect the virus faster than the current standard, can also be performed on patients who meet risk factors such as traveling from Guinea, Liberia and Sierra Leone, where the current outbreak is centered.
But the test has not been approved by the FDA for general use, The Wall Street Journal reported.
Meanwhile, the global death toll from Ebola has risen to 7,693 out of 19,695 confirmed cases recorded in the year-old epidemic in West Africa, the World Health Organization said on Dec. 26.
