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FDA Grants Emergency Use Authorization for Zika Test

FDA Grants Emergency Use Authorization for Zika Test

In anticipation of an expected increase in the number of Zika cases heading into the summer months, the U.S. Food and Drug Administration has given the go-ahead for Hologic Incorporated to immediately use and sell its Aptima® test to detect the Zika virus in human plasma and serum. Hologic says it will immediately make its test available in all 50 states, Puerto Rico, and U.S. territories. This makes the third commercially available test for the detection of Zika. Focus Diagnostics and Altona Diagnostics GmbH out of Germany were previously granted emergency authorization to use their version of the Zika virus test.

The Latest U.S. Zika Statistics

As of June 15, 2016, the U.S. Centers for Disease Control reports a total of 756 cases of Zika in the United States. All but one of the cases has been linked to travel in areas with a high rate of local infection. The remaining case was acquired in a laboratory setting. So far, there are no reports of locally-acquired cases of Zika within the U.S.; however, health officials expect this to change over the summer mosquito season. More than 1,400 cases of locally-acquired Zika have been reported in various U.S. territories.

The Risk of Zika

The Zika virus has been linked to a high risk of birth defects when contracted during pregnancy, including microcephaly. Microcephaly is a devastating birth defect characterized by an abnormally small head and brain and severe developmental defects. As of June 9, 2016, three babies have been born in the U.S. with suspected Zika-related birth defects. There are also three reported cases of lost pregnancies connected to Zika. Currently, there are 234 pregnant women in the U.S. with evidence of possible Zika infections, so these numbers could change dramatically as these women deliver over the coming months.

Additional Steps by the CDC

The CDC has established a national registry for the reporting of poor pregnancy outcomes related to Zika. All laboratory-confirmed cases of Zika virus are required to be reported to the CDC. According to the CDC, this information is essential in helping federal, state, and local health officials and clinicians provide the necessary support to those affected by the Zika virus.


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