FDA Gives Roche Emergency Authorization for Ebola Tests on Detection of Virus

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The World Health Organization (WHO) has recorded over 7,500 confirmed, and suspected Ebola deaths in the West African countries of Liberia, Sierra Leone, and Guinea; and more than 19,000 recorded cases in the said trio which are, hitherto, the most heavily-affected countries in terms of Ebola. Early detection and quick action are therefore necessary to curb the further spread of the disease.

The emergency authorization given to pharmaceutical company Roche Holding for an Ebola virus test may help health care authorities around the world to fight the outbreak of the disease which has claimed an alarming number of lives in West Africa.

U.S Food and Drug Administration has authorized Roche use of its LightMix (R) Ebola Zaire rRT-PCR Test on patients with signs and symptoms of the Ebola virus, as well as those with risk factors such as travel from the disease's hardest-hit countries. The letters in the test name stand for "real-time reverse transcription polymerase chain reaction."

According to Roland Diggelman, chief operating officer at Roche's diagnostics division, the test would allow "health-care professionals to quickly detect the virus and start patient treatment as early as possible."

As per Roche's press release, the LightMix test can generate results in just over three hours, helping detect the virus quickly, and making treatment start as soon as possible.

The test is manufactured by Berlin-based TIB MOLBIOL GmbH and distributed exclusively by Roche. Under the emergency use designation, certain laboratories in the United States and other countries have been authorized to use the test for a limited period to detect the type of Ebola that has been spreading in West Africa.