FDA Grants Emergency Use Authorization to Three Ebola Diagnostics

The FDA has authorized emergency use of three in vitro diagnostic for detecting the Ebola virus, which ravaged West Africa last summer and fall.

EUAs for Salt Lake City-based BioFire’s FilmArray NGDS BT-E Assay and FilmArray Biothreat-E test took effect Oct. 25, according to the Feb. 9 Federal Register notice. The NGDS BT-E is a real-time reverse transcriptase polymerase chain reaction that detects Ebola in whole blood specimens from individuals with symptoms of the virus or risk of exposure. The Biothreat-E is an automated reverse transcriptase PCR system for detecting Ebola in whole blood or urine specimens.

An EUA was also issued for San Jose, Calif., diagnostics maker altona’s RealStar Ebolavirus RT-PCR Kit 1.0. The test detects RNA from Ebola viruses in human plasma specimens. The EUA was effective Nov. 10.

EUAs are issued for unapproved products that are needed to diagnose, treat or prevent a serious or life-threatening disease or condition, and for which some well-controlled clinical data is available. The FDA must consult with HHS, the National Institutes of Health and the Center for Disease Control and Prevention CDC before issuing an EUA.

Read the Federal Register notice at www.fdanews.com/02-09-15-EbolaEUA.pdf. — Kellen Owings