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June 25, 2016: FDA Allows Emergency Use of Hologic’s Aptima Test for The Zika Virus

Brad Perriello reports “Hologic said it won an emergency use exemption from the FDA for its Aptima diagnostic to detect Zika virus.

“The approval covers the detection of the Zika virus in human serum and plasma specimens and makes the test available immediately in the U.S., Puerto Rico and U.S. territories, Marlborough, Mass.-based Hologic said.

“’We want to ensure that during this critical summer season and beyond, those at risk for the Zika virus have an opportunity to be tested with a highly sensitive assay,’ Hologic medical director Dr. Edward Evantash said in prepared remarks. ‘Our new test will help to ensure accurate diagnoses and reduce subsequent spread of the infection.’

“Last week U.S. officials said three babies were born here with defects that were most likely caused when their mothers contracted the mosquito-borne virus during pregnancy.”

Source: Mass Device

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