FDA OKs emergency authorization of Ebola blood test distributed by Roche
The Food and Drug Administration granted an emergency use authorization for a blood test that can quickly detect the Ebola Zaire virus in patients who are showing signs of being infected.
The LightMix Ebola Zaire rRt-PCR Test, which has not been approved by the FDA, can produce results on dozens of samples in just over three hours after they have been prepared, according to Swiss drugmaker Roche, which distributes the test.
A German company, TIB Molbiol GmbH, makes the test, which also uses Roche instruments.
The Ebola Zaire virus has been detected in a West African Ebola outbreak that has killed more than 5,600 people over the past several months, mostly in Guinea, Liberia and Sierra Leone.