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Houston Methodist and Texas Children's Hospital announced last month they'd collaborated on the first hospital-based testing for the Zika virus that offered quick results. Researchers say the test is designed for pregnant women who show symptoms, or who have traveled to countries where the virus is prevalent.
The announcement received a lot of fanfare but the hospitals soon got a letter from the Food and Drug Administration. It wasn't to the level of a warning letter, but the FDA said it wanted to know if the hospitals were marketing a high-risk test that hadn't been pre-approved, and it requested more information on how the test was developed. Several other laboratories that are working on Zika testing also got similar letters.
In a statement on behalf of both hospitals, Texas Children's says there has been no request to stop the testing:
“Texas Children’s Hospital and Houston Methodist Hospital developed the country’s first hospital-based rapid tests for the Zika virus. The Food and Drug Administration contacted us for further details about our tests. We understand they are also doing this with other laboratory developed Zika tests. As requested, we are working collaboratively with them and sharing information regarding the tests’ design, validation and performance characteristics. The FDA has not asked us to discontinue use of our tests. Currently, our rapid Zika tests are only offered to our registered patients. At Texas Children’s and Houston Methodist we are committed to innovation and providing our patients with the highest-level of diagnostic testing, treatments and care.”
The mosquito-borne Zika virus has been linked to birth defects in some children.
See the letter from the FDA below:
