According to a June 20th Mass Device article, Hologic has secured emergency use exemption from the FDA for two Zika virus assays, Aptima and Procleix. The latter, which belongs to both Hologic and Grifols, is a virus assay that screens blood supplies. The exemption was enabled by the FDA’s Investigational New Drug protocol and makes the tests available immediately in the U.S., Puerto Rico, and U.S. territories where the virus is an endemic.
The FDA’s website states, “Emergency use is the use of an investigational device in an emergency situation. It is intended to provide patients and physicians with access to devices intended to treat life-threatening or serious diseases or conditions when there is no available alternative and no time to obtain FDA approval.”
Zika is a virus linked to microcephaly, a birth defect characterized by an unusually small head and possible developmental complications. The World Health Organization (WHO) declared the virus a global emergency in February. Over 1,400 cases of Zika-related microcephaly cases have been reported in Brazil as it prepares to host the Olympics in August. However, the WHO said last week that the risk of Zika infection is very low among athletes and attendees.