Gulf Coast Regional Blood Center plans to begin testing blood donations for the Zika Virus beginning May 23.
The test is part of an Investigational New Drug Application protocol approved by the U.S. Food and Drug Administration. The cobas® Zika test is manufactured by Roche Molecular Systems.
“The Blood Center is trying to be proactive regarding the Zika virus,” said Dr. Susan Rossmann, Chief Medical Officer of The Blood Center. “We have agreed to help in development of a new test to do whatever we can to minimize the risk of transmission of the virus via transfusion.”
The Blood Center is currently in the planning and pre-implementation phases of the clinical trial. It is one of only a few blood centers in the United States participating in the trial.
Due to the test being in a trial stage, all donors must sign a consent form in order for the test to be administered to their blood.
Roche is the world’s largest biotech company and a global pioneer in pharmaceuticals and diagnostics.
“As a leader in diagnostics, Roche is committed to providing testing solutions for the world’s most challenging healthcare emergencies,” said Uwe Oberlaender, Head of Roche Molecular Systems. “With the collaboration of the FDA on this IND, we are able to further expand our commitment to help keep the blood supply safe.”
On the continental United States, there have been no cases of Zika transmission from mosquitos. All known Zika cases on the mainland have been people who have traveled to countries affected by the virus or females who have had sexual contact with someone that has been in those areas within the past 28 days.
Until the testing begins, The Blood Center will continue to help safeguard the blood supply and protect the patients it serves by deferring donors who could potentially carry the Zika virus. The Blood Center is currently deferring all presenting donors who have traveled to regions including Mexico, the Caribbean, and Central and South America within the past 28 days as part of the required screening process. It is also asking all female donors that have had sexual contact with a man who has had a Zika virus infection or has traveled to one of the infected areas in the previous three months, to not donate until at least four weeks after their last sexual contact within that three-month window.
The Blood Center continues to work closely with local public health officials to stay proactive regarding the Zika virus.
The Blood Center is the primary supplier of blood components to more than 170 hospitals and health care facilities in a 26-county Texas Gulf Coast region.