Zika Diaries: FDA approves Zika diagnostic test of Roche
The U.S. Food and Drug Administration issued emergency authorization for a Zika diagnostics test from Swiss drugmaker Roche, skirting normal approval channels as the regulator moves to fight the disease’s spread.
Zika virus, detected in Brazil and elsewhere last year before spreading to the Americas, is associated with microcephaly, a birth defect characterized by an unusually small head and potential developmental problems.
Through last week, the United States reported 2,517 Zika cases, 29 of which were likely acquired locally in Florida through mosquito bites and the rest brought in by travelers, the U.S. Centers for Disease Control and Prevention (CDC) said.
Some 9,000 additional cases have been reported in U.S. territories, including Puerto Rico. With FDA approval, Roche’s test now can be used to screen patients exhibiting Zika symptoms that meet CDC criteria, including fever, rash, joint pain and red eyes. Samples will be sent for analysis to specially-certified U.S. laboratories with the appropriate equipment, a Roche spokesman said.
“The LightMix Zika test is an easy-to-use molecular diagnostic test that enables healthcare professionals to quickly detect the virus,” said Uwe Oberlaender, Head of Roche Molecular Diagnostics.
“As a leader in diagnostics, Roche
is committed to providing testing solutions for the world’s most challenging healthcare emergencies. The FDA’s granting of this EUA supports our commitment to help healthcare professionals who are working to combat this serious disease.”In addition to the LightMix® Zika rRT-PCR Test, Roche has also developed the cobas® Zika Test for use with the cobas® 6800/8800 Systems. This test is available under an Investigational New Drug Application (IND) protocol to initiate collection and testing of blood samples for screening. It is currently being utilized in blood centres in the United States.
The FDA issues such Emergency Use Authorization during public health emergencies, to quickly deploy unapproved medical products for as long as they are needed.
As Zika cases caused by local Aedes aegypti mosquitoes in Florida mount and travelers from elsewhere continue to arrive with the disease, the FDA last week recommend universal testing of donated blood across the United States.
In Brazil, Zika virus has been linked to more than 1,800 cases of microcephaly, and U.S. officials expect as many as 270 cases in Puerto Rico.
