FDA allows emergency use of Hologic’s Aptima test for the Zika virus

Hologic (NSDQ:HOLX) 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.

Zika, which the World Health Organization declared a global emergency in February, has been linked to microcephaly, a birth defect characterized by an unusually small head and potential developmental problems.

“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.”

“Our new Aptima Zika virus assay is another reflection of our commitment to developing cutting-edge diagnostics that provide solutions for urgent unmet needs,” added diagnostic solutions president Tom West. “Running the Aptima Zika virus assay on the Panther system will offer quick results to epidemiologists and laboratories, which is likely to help both healthcare providers and their patients.”

Last week U.S. officials said 3 babies were born here with defects that were most likely caused when their mothers contracted the mosquito-borne virus during pregnancy.

More than 1,400 Zika-related microcephaly cases have been confirmed in Brazil, which is preparing to host the Olympic games in August. The WHO said last week that the risk of Zika infection for athletes and attendees is very low.

HOLX shares closed up 0.3% June 17, at $33.81 apiece. The stock gained another 1.5% in after-hours trading that day, climbing to $34.30 per share.

Material from Reuters was used in this report.

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