Dive Brief:
- HHS announced efforts are underway to evaluate a test to identify the Zika virus in donated blood with support from the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response (ASPR) and the Office of the Assistant Secretary for Health (OASH).
- The plan follows the FDA's March 30 announcement of the availability of an investigational test to screen donations for Zika, manufactured by Roche Molecular Systems.
- The new agreement supports a clinical study to evaluate the test's sensitivity and specificity during actual use as U.S. health officials call more attention to efforts at prevention.
Dive Insight:
While the investigational test is already available for blood establishments in Puerto Rico and could be used under an investigational new drug application (IND) in other areas with mosquito-borne Zika transmission, the current study is needed for FDA approval for commercial marketing.
HHS noted the majority of people with Zika do not experience symptoms and could unwittingly donate blood while infected, which most particularly puts pregnant women and women of child-bearing age at risk of having infants born with microcephaly.
Probable cases of Zika transmission by blood transfusion have been reported in Brazil and are under investigation.
Under the new $354,500 contract with Roche, the company will study blood samples to confirm whether the test is reliable at identifying Zika even in very low concentrations.
Meanwhile, HHS Secretary Sylvia Burwell is set to visit Puerto Rico April 26 as part of the U.S. strategy to monitor the virus and promote prevention efforts.