- The FDA on Wednesday approved the use of an experimental test to screen blood donations for Zika virus. Manufactured by Roche, the test will be allowed for use in areas with active transmission of Zika, such as Puerto Rico.
- In February, the agency issued guidance recommending against collecting blood in Zika-endemic areas. This brought local blood collection in Puerto Rico to a halt. The Department of Health and Human Services has since set up shipments of blood from the continental U.S. to the island territory.
- However, the guidance allowed blood collection in Zika-affected areas if a screening test is available. This is where Roches's experimental test comes in.
The introduction of an investigational test to screen for Zika virus is the result of a collaborative effort between the FDA and Roche. The availability of the test allows blood establishments to maintain the integrity of the blood supply and comply with FDA safety guidelines.
Peter Marks, director of the FDA's Center for Biologics Evaluation and Research, emphasized the long-term public health benefits of using the investigational test. "In the future, should Zika virus transmission occur in other areas, blood collection establishments will be able to continue to collect blood and use the investigational screening test, minimizing disruption to the blood supply," said Marks.
Roche's test should reduce the reliance on blood importation in Puerto Rico, the company said. As Zika virus continues to spread in the Americas, this test could come into use in other areas including southern regions of the continental U.S.
The test is manufactured in New Jersey by Roche Molecular Systems.