FDA Issues Emergency Authorization for Roche Zika Test
On Monday, the US Food and Drug Administration skirted normal approval channels and issued Emergency Authorization for a Zika diagnostic test from the Swiss drug maker Roche.
The US Food and Drug Administration (FDA) is facing several challenges in fighting the spread of the Zika Virus. On Monday, they skirted normal approval channels and issued Emergency Authorization for a Zika diagnostic test from the Swiss drug maker Roche. According to the Centers for Disease Control and Prevention (CDC), the United States has reported more than 2,000 cases.
Approximately 9,000 cases have been reported in US territories, including Puerto Rico, where as many as 270 cases of microcephaly, a birth defect caused by the virus, are expected. In Brazil, Zika has been linked to more than 1,800 cases of microcephaly.
With FDA approval, Roche may now use the LightMix Modular Zika Virus Assay (CE) test. This “easy-to-use molecular diagnostic test,” will enable healthcare professionals to quickly detect the virus, according to Roche. Uwe Oberlaender, Head of Roche Molecular Diagnostics, in an announcement released by Roche said. “As the worldwide leader in molecular diagnostics, Roche is committed to providing diagnostic solutions for the world’s most challenging health emergencies.”
In addition to CE, Roche has also developed the cobas Zika test for use with the cobas 6800/8800 Systems. This test has been approved by the FDA to initiate collection and testing of blood samples. It is currently being utilized in blood centers in the United States.
As Zika cases in Florida continue to rise and travelers arrive infected, the FDA issued Emergency Use Authorization, considering this a public emergency. This unapproved medical product will be deployed for as long as it is needed.
Diagnosis of Zika is based on a person’s recent travel history, symptoms, and test results. The CDC recommends testing for people who have been exposed to Zika through sex and who have symptoms. Pregnant women with possible exposure should also be tested. There is no specific medicine or vaccine for Zika, if you think you have or had Zika, treat the symptoms and protect others from contracting the illness.