FDA Authorizes Emergency Use of Roche Ebola Zaire Test
The FDA has granted an emergency use authorization for Roche’s LightMix Ebola Zaire rRT-PCR Test. The diagnostic will be used to confirm the presence of virus in patients with signs of infection or other risk factors, such as recent travel in West Africa.
Under the EUA, announced Monday, performance of the test in the U.S. will be restricted to CLIA high complexity laboratories.
The one-tube duplex assay uses whole blood samples to detect the virus. It is run on Roche's LightCycler 480 or cobas z 480 instruments and can process as 96 samples in three hours, according to the Swiss company.
Roche will distribute the test under an exclusive license with German life sciences company TIB MOLBIOL GmbH, which manufactures the test. The LightMix Ebola Zaire test is already CE-marked and available in markets that observe the mark. TIB MOLBIOL has also requested an emergency assessment by the World Health Organization, Roche said. — Kellen Owings