Photo by Juan D. Alfonso
The US Department of Health and Human Services (HHS) is providing financial support for a clinical trial of the cobas® Zika test, which is designed to screen blood donations for Zika virus.
The US Food and Drug Administration (FDA) recently authorized the use of this test, under an investigational new drug application protocol, for screening donated blood in areas with active, mosquito-borne transmission of Zika virus.
This means the cobas® Zika test can be used by US blood screening laboratories, but the laboratories will need to be enrolled in and contracted into the clinical trial as specified and agreed with the FDA’s Center for Biologics Evaluation and Research.
Now, the HHS has announced that the Biomedical Advanced Research and Development Authority (BARDA) is supporting the trial, which will evaluate the sensitivity and specificity of the test in its actual use.
The trial is necessary for Roche, the company developing the cobas® Zika test, to apply for FDA approval for commercial marketing.
“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 US blood supply,” said Richard Hatchett, BARDA’s acting director.
“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.”
Under the 1-year, $354,500 contract, Roche will study blood samples to confirm whether the test accurately and reliably detects and identifies Zika virus, even when present in very low concentrations in donor blood.
