Feb 20, 2019 | Updated: 10:02 AM EST

FDA Approves New Roche Ebola Test For Emergency Use

Dec 29, 2014 04:59 PM EST


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  the most heavily-affected countries in terms of Ebola. Early detection and quick action are therefore necessary to curb the further accelerated spread of the disease.

The emergency authorization given to pharmaceutical company Roche Holding for an Ebola virus test may help health care officials around the world to better fight and detect the outbreak of the disease, which has claimed an alarming number of lives in West Africa and has spread to numerous countries since its emergence last year.   

U.S Food and Drug Administration has authorized Roche use of its current 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, as subjects in the clinical trials of the new test. The test named RRTPCR, is an acronym that  stands for "real-time reverse transcription polymerase chain reaction", though it is commonly referred to as the LightMix test.

According to Roland Diggelman, chief operating officer at Roche's diagnostics division, the test will 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 treatments available 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.

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