Issue Date: May 9, 2016 | Web Date: May 6, 2016
FDA approves first commercial test for Zika
Quest says it plans to make the test widely available to doctors for patient testing starting in early May. Previously, Zika screening tests were available only through the federal Centers for Disease Control & Prevention for use in a network of labs approved by CDC.
“The availability of our new molecular Zika test provides physicians broad access to a diagnostic tool for managing the Zika outbreak,” says Rick L. Pesano, vice president of research and development at Quest, a clinical laboratory services company.
The new test detects RNA from the Zika virus in blood samples. Quest says the test results will initially be processed at a laboratory in San Juan Capistrano, Calif., which developed and validated the technology.
The virus, which is mainly spread through mosquito bites, has become an epidemic in Latin America and the Caribbean. Health officials have confirmed that infection during pregnancy can cause fetal microcephaly and other birth defects and have warned that outbreaks in the U.S. are possible.
The Obama Administration is seeking funding to expand programs that control mosquitoes and for research into vaccines, but the $1.8 billion request is being held up in Congress.
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