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Monday, February 6th, 2023

FDA authorizes first Zika diagnostic test for marketing

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The U.S. Food and Drug Administration (FDA) has permitted the first test to locate Zika antibodies in human blood to be marketed.

The ZIKV Detect 2.0 IgM Capture ELISA is the first Zika diagnostic test that has been authorized for marketing in the United States. Until now, 18 other active tests have existed but were only allowed under emergency use.

“At the onset of the Zika virus outbreak, when little was known about the disease or how to diagnose it, the FDA worked quickly with manufacturers to encourage the development of diagnostic tests and ensure they were available using our emergency use authorities,” FDA Acting Commissioner Ned Sharpless said. “Today’s marketing authorization is a great demonstration of the FDA’s work to protect the public health in emergency response situations. We ensured there were tests made available quickly under EUA, but we continued to work with diagnostic manufacturers to take the next step of ensuring products were FDA reviewed for safety and effectiveness and authorized under our traditional premarket authorities.”

The new test detects the proteins produced by the body’s immune system when it tests for Zika virus infection in the blood. Zika authorized it following review of a clinical study of 807 test samples and various analytical studies. That said, the test will only be usable by those patients with clinical signs and symptoms of Zika infection, or who have traveled to regions with active Zika transmission.

There is, however, a margin of error in the test. Negative results are possible in samples taken before the fourth day of symptom onset, or after IgMs are no longer detectable.

Marketing authority for the test has been granted to InBios International, Inc.