Hologic's Zika test can be used on emergency basis, FDA says
- Hologic's Aptima Zika virus assay last week was granted emergency authorization by the FDA, adding another diagnostic option to test for the rapidly spreading mosquito-borne illness.
- Although not equivalent to an approval, the authorization will permit labs to use Hologic's diagnostic to test patients who are either at risk of exposure to Zika or have symptoms of the virus during the emergency period.
- Several other diagnostics have already been granted emergency authorization by the FDA, including one from Quest Diagnostics and another from the Centers for Disease Control and Prevention. Roche also has a test cleared for emergency screening of blood donations.
In January, when Zika began triggering international concern, experts saw an eventual spread north from South and Latin America as inevitable. That has been borne out, as warmer summer months and travel between endemic countries has helped the virus spread, now beginning to reach the U.S.
While the main viral vector for Zika is the Aedes mosquito, sexual contact is now also thought to be a means of transmission. Zika has been linked to a number of birth defects, most notably mircocephaly, in babies born to mothers with the virus.
So far, six babies in the U.S. have been born with evidence of Zika-related birth defects, according to the Centers for Disease Control and Prevention. And as of earlier this month, 234 women in the U.S. had tested positive for Zika.
Although Zika is not normally a life-threatening, and symptoms often go undetected, the World Health Organization has declared it a public-health emergency due to the link to birth defects. The global health agency recently said it will need over $120 million to combat the virus.
The emergency authorization of Hologic's test helped the company's stock climb in after-hours trading Friday, although some of those gains had been pared back Monday.