Hologic (NSDQ:HOLX) said it won an emergency use exemption from the FDA for its Aptima diagnostic to detect Zika virus and for it and Grifols (NSDQ:GRFS) Procleix Zika screening assay under the FDA’s Investigational New Drug protocol.
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.”
The joint Procleix Zika screening assay runs on the Procleix Panther system, according to Hologic. Blood centers in the U.S. will use the Procleix Zika virus assay to screen donated blood collected in potentially endemic areas in the southern U.S., Hologic said.
“The American Red Cross is pleased to participate in the Procleix Zika Virus assay investigational study, which will allow us to begin blood donor testing for Zika virus early this summer in areas most likely to have local mosquito transmission of the virus. Working together, we remain committed to ensuring the safety and availability of the U.S. blood supply for patients in need,” American Red Cross scientific affairs veep Susan Stramer said in a prepared statement.
Use of the Procleix Zika assay may expand testing to other areas in the U.S. if the virus continues to spread, Hologic said.
“Zika virus is a rapidly growing threat to public health. Today’s announcement demonstrates our ability to quickly develop molecular diagnostics in response to new and emerging pathogens,” Hologic diagnostic solutions division prez Tom West said in a press release.
“As a global leader in Transfusion Medicine. Grifols is proud to serve blood banks and healthcare professionals working around the world to ensure patients receive safe blood transfusions,” Grifols diagnostic division prez Carsten Schroeder said in prepared remarks.
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.
