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FDA Approves Rapid Ebola Test, Drastically Reducing Diagnosis Time

The U.S. Food and Drug Administration has approved a rapid diagnostic tool for Ebola screening.

The Swiss pharmaceutical company, Roche, announced on Monday that its test is approved for emergency use only, meaning that some labs in the United States and abroad can use it for a restricted amount of time but it’s not yet available to the general public.

LightMix Ebola Zaire rRT-PCR Test can detect the virus in about three hours; the standard Ebola tests can take about a day.

The test looks for a specific pattern in the messenger ribonucleic acid (mRNA); these molecules carry genetic information from the DNA to inside the cells. The test interprets the genetic material on this mRNA strand to the corresponding DNA strand and then millions of copies of the DNA strand is made so the clinician can see whether this particular DNA strand is that of the virus. The test uses a process called a polymerase chain reaction to copy the DNA over and over again.

The acronym, RT-PCR, stands for reverse transcriptase polymerase chain reaction. “The LightMix’s fast turnaround allows healthcare professionals to quickly detect the virus and start patient treatment as early as possible,” said Roland Diggelman, COO of Roche Diagnostics Division, to Fortune.

Lightmix is one of the diagnostic tools approved by the FDA in 2014 as the ebola epidemic still ravages West Africa and is a great concern all over the world. Currently, the World Health Organization reports that total number of known and suspected cases surpasses 20,000 and known and suspected deaths from the disease climb towards 8,000. The numbers are most likely an underestimate of the true damage.

Thus, Roche’s new diagnostic test means that treatment can be available to patients earlier, however the test must still be performed in a lab. For tens of thousands of Africans living in remote villages with little infrastructure, it’s not clear how this breakthrough can help curb the epidemic.

S.C. Rhyne is a blogger and novelist in New York City. Follow the author on Twitter @ReporterandGirl, and visit her website at

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