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FDA Wants Hologic Zika Virus Emergency Use Authorization to Include Urine Samples

Sep 12, 2016 06:05 AM EDT
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The U.S. Food and Drug Administration (FDA) has expanded the emergency use authorization (EUA) for Hologic's Zika virus diagnostic assay to be used with urine samples.

In June 2016, the FDA authorized the emergency use of Hologic's Zika virus assay with serum and blood samples. But following the new announcement, the assay will now be used with urine samples, which would lengthen the time period during which patients could be tested for Zika virus after showing symptoms, from seven to 14 days, as recommended by the Centers for Disease Control and Prevention (CDC).

"This action by FDA is significant because it gives many more people the opportunity to be tested with our highly sensitive assay," Tom West, division president of Diagnostic Solutions at Hologic, said in a press release. "In particular, this expanded indication allows us to better serve public health labs, increasing access to more people to detect and diagnose more disease."

The Aptima Zika Virus assay is a molecular diagnostic tool that detects RNA from Zika virus in human specimens. While the assay does not have clearance or approval from the FDA, it can be used for the duration of the emergency use authorization in vitro diagnostic tests for detecting the presence of Zika virus or diagnosis of the virus infection.

In May, CDC recommended doctors to conduct urine tests when checking patients who show symptoms of Zika infections. The advice for additional testing procedure came after new research data had shown that traces of the virus had been retained longer -- about a week longer -- in urine than in blood

Hologic, Inc. is a leading developer, manufacturer and supplier of premium diagnostic products, medical imaging systems and surgical products. The Aptima Zika virus assay runs on the Panther system, which is an integrated platform that allows for full automation of all aspects of nucleic acid amplification testing. The system significantly reduces hands-on time as well as minimizes labor needs and manual errors.

The assay is designed to be used in individuals who meet the CDC's Zika virus clinical criteria, which include those who show signs and symptoms associated with Zika virus infection, as well as those who have a history of residence or travel to Zika-affected regions.

Local transmission of the mosquito-borne virus has been reported in Florida's Miami-Dade County. Just recently, the state reported that 84 pregnant women have tested positive for the virus, including 15 who have already given birth. Excluding the number of affected pregnant women, officials said that 56 people have contracted the virus locally, while 604 have been infected while traveling.

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