HHS Grant Brings Roche's Zika Blood Test One Step Closer to FDA Approval

A sector of the US Department of Health and Human Services (HHS) will support Roche Molecular Systems Inc., of Branchburg New Jersey, in conducting trials to evaluate the company’s Zika blood screen test.

Because around 80% of individuals infected with Zika are asymptomatic, it is important for those who donate blood to be tested for the virus. In February 2016 the World Health Organization reported that two cases of Zika infection in Campinas, Brazil were due to blood transfusion. In response, the Centers for Disease Control and Prevention (CDC) released guidelines that halted local blood donation collection from United States territories if active Zika infection is declared, for fear of a Zika epidemic. Since then, the US Food and Drug Administration (FDA) approved an investigational blood screen test to examine blood donations for the Zika virus.

In a recent press release, the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response’s (ASPR) Biomedical Advanced Research and Development Authority (BARDA) announced that it will grant the pharmaceutical company an award to conduct clinical studies to evaluate the test in its “actual use,” a crucial step for FDA approval for commercial marketing.

The BARDA award will grant the company a 1-year contract and $354,500 to go towards analyzing blood samples to examine the effectiveness of the test to detect Zika, even in very low concentrations of viral presence. BARDA’s support of preparing the blood screen test for FDA approval stems from its integrated portfolio intended for “advanced research and development, innovation, acquisition, and manufacturing of vaccines, drugs, diagnostic tools, and non-pharmaceutical products for public health emergency threats…. [such as] chemical, biological, radiological, and nuclear agents, pandemic influenza, emerging infectious diseases, and antimicrobial resistance.”

Commenting on the importance of a Zika blood screen test, Richard Hatchett, MD, acting director of BARDA stated, “BARDA staff has worked closely with our partners at FDA and the Office of the Assistant Secretary of Health to ensure the continuity and safety of the U.S. blood supply. Today’s award to Roche is an important step towards securing the safety of the blood supply in Puerto Rico and in the rest of the United States.”