By Mary Elizabeth Dallas
"Today's action represents the first approval of a Zika virus detection test for use with screening the nation's blood supply," Dr. Peter Marks said Thursday in an agency news release. Marks is director of the FDA's Center for Biologics Evaluation and Research.
"Screening blood donations for the Zika virus is critical to preventing infected donations from entering the U.S. blood supply. Today's approval is the result of a commitment by the manufacturer to work rapidly and collaboratively with the FDA and the blood collection industry to respond to a public health crisis, and ensure the safety of blood in the U.S. and its territories."
Zika is spread mainly through mosquitoes carrying the virus. It can also be transmitted through sexual contact or blood transfusions.
In August of last year, the FDA advised all states to screen all donated blood and blood products with an experimental screening test accessible under an investigational new drug (IND) application.
An IND allows the FDA to authorize use of an experimental drug in emergency situations. The FDA recommended that an experimental Zika screening test be used until an approved test became available.
Several blood collection centers opted to use the cobas Zika test, which is made by Roche Molecular Systems.
Results from these screenings along with studies conducted by Roche showed the test is an effective way to screen donated blood for the virus. Five different labs found the test accurately identified 99 percent of all infected blood samples.
Zika can cause devastating birth defects in babies whose mothers are infected with the virus while pregnant. The most common of these is microcephaly, a condition in which the baby's head and brain is small and underdeveloped. Thousands of babies in Brazil were born with catastrophic neurological defects linked to the virus when the Zika outbreak there was at its height in 2015 and 2016.