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FDA Expands Hologic Zika EUA to Include Urine Testing

NEW YORK (GenomeWeb) – The US Food and Drug Administration has expanded the Emergency Use Authorization issued to Hologic's Aptima Zika test to include urine testing, the company announced today.

The new claim enables testing of urine that is collected alongside plasma or serum from patients meeting the US Centers for Disease Control and Prevention clinical or epidemiological criteria for Zika testing. The Aptima Zika test, which runs on Hologic's Panther platform, can now be used on urine samples up to 14 days after a suspected infection, as opposed to seven days for blood or plasma.

The CDC issued updated guidelines in May advising that urine samples should be used for PCR-based Zika testing between seven and 14 days after possible infection, since the virus appears to be detectable for a longer period in urine than in blood samples. Less than seven days after infection, urine should be tested in conjunction with serum, the agency said. Of the eight molecular tests granted EUA status so far, six are now authorized for urine testing. 

"This action by the 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 statement. The expanded indication allows Hologic "to better serve public health labs, increasing access to more people to detect and diagnose more disease," he added. 

The assay is available for use in all 50 states, Puerto Rico, and US territories.

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