FDA Approves Investigational Zika Virus Blood Screen Test

In the wake of a global Zika scare, and in light of the possibility of a Zika outbreak in the coming months, the FDA has allowed the use of an investigational test to screen blood donations for the Zika virus.

Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research discussed the importance of having a test to screen for Zika, noting that it is “an important step forward in maintaining the safety of the nation’s blood supply, especially for those US territories already experiencing active transmission.”

After local Zika transmission was seen in Puerto Rico, the country stopped accepting blood donations under the implementation of an FDA guidance for the screening of donor blood. Section B of the guidance recommended that areas with active transmission of Zika virus “obtain whole blood and blood components for transfusion from areas of the US without active transmission of [the Zika virus] to fulfill orders.” It was further advised that the collection and preparation of platelets and plasma may be done locally if an FDA-approved pathogen reduction device is used as specified in the guidelines. The collection of blood components may be done locally once a Zika virus FDA-licensed blood screening test is available.

With this test now accepted under an investigational new drug application, Puerto Rico, and other US territories which have locally-transmitted Zika cases, may commence the collection of local blood donations.

The FDA, the CDC, and the Office of the Assistant Secretary for Preparedness and Response/Biomedical Advanced Research and Development Authority are collaborating with product manufacturers, such as New Jersey’s Roche Molecular Systems, Inc. which manufactured this test, to help develop Zika virus blood donation screening tests.

Luciana Borio, MD, the FDA’s acting chief scientist, said that the FDA and US government partners are known to cooperate with manufacturers during public health emergencies. She stated that “the close collaboration between the FDA and the product manufacturer was essential to expediting availability of this investigational test.”