FDA Approves Experimental Zika Screening For Blood Donations
KELLY MCEVERS, HOST:
The federal government has been paying for blood banks around the country to ship blood to Puerto Rico. The FDA issued guidelines last month to stop blood donations on the island because of the Zika virus. The virus is most commonly transmitted through mosquitoes, but Brazil has reported cases of transmission through blood transfusions. Puerto Rico has more than 300 reported Zika cases.
Within the next week or two, Puerto Rico will be able to start collecting blood again. That's because the FDA has just give the go-ahead to a new test to screen blood donations for the virus. Peter Marks is the director of the FDA's Center for Biologics Evaluation and Research. Welcome to the show.
PETER MARKS: Thanks very much.
MCEVERS: This test was developed by the drug company Roche, and it will be used on what's called an investigational basis. First, can you tell us what that means?
MARKS: So investigational use of a test means that data continue to be collected on the tests performance at specific participating sites that are conducting the test. And that means that the test itself has not yet received approval to be marketed commercially.
MCEVERS: Is there any question at all about whether or not this test actually works?
MARKS: So the best way that I can answer that is to say that, yes, the test is under investigational use. But before we allowed this investigation - new drug application to proceed, we carefully considered any potential risks prior to determining that it was safe for it to proceed.
And we also considered the possibility that the test might malfunction in a manner that could put patients at risk. And we consider the latter really highly unlikely. So we feel that it was reasonable to allow this test to proceed at this time.
MCEVERS: OK. I mention that blood banks from all over the U.S. have been sending blood to Puerto Rico. Was there a real possibility of a blood shortage if Zika were to spread to Florida or other Gulf states?
MARKS: The good news is that currently, the blood supply in the United States is quite adequate. And there actually is an interorganizational disaster task force which has been monitoring the situation and feels that, at least at this point, the blood supply would be adequate to meet the needs would there have been spread of Zika to a larger area on the continental United States.
MCEVERS: So let's say if Zika were to be transmitted elsewhere in the U.S., could this test be rolled out quickly to affected areas?
MARKS: So I'm going to have to defer part of that to the sponsor, Roche. But my understanding is that they are aware of the potential need that this could be a larger outbreak than the existing one in Puerto Rico.
MCEVERS: If you can, put this in perspective for us in terms of other developments regarding Zika.
MARKS: So in terms of the perspective of having a blood screening test, I would say that this is a major step forward in helping to keep the blood supply safe. It will allow blood to potentially be collected in areas where there is active transmission, which is quite important for something like Zika which could be transmitted by either mosquitoes or could possibly be sexually transmitted. So we feel it is a step forward.
MCEVERS: Dr. Peter Marks heads the FDA's Center for Biologics Evaluation and Research. Thank you very much.
MARKS: Thank you.
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