US Officials: Work On Tests To Discern Zika From Dengue Could Slow Without Steady Federal Funding
Scientists from US FDA and other health agencies are working to develop and rapidly approve tests that can clearly and quickly detect Zika virus from Dengue fever. But without a steady source of funding for countermeasures, progress to fight Zika may slow, even while the emergence of mosquito-borne diseases accelerates, agency officials said.
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The US agency issued a guidance document that significantly lowers regulation of diagnostics used specifically to fight the ongoing COVID-19 pandemic. The new policies give states far more autonomy, allow diagnostics makers to distribute products before an Emergency Use Authorization is issued by the FDA, and permits certain serological tests on the market if they adhere to proper labeling.
Three US health-care agencies – FDA, the Centers for Disease Control and Prevention, and the Centers for Medicare and Medicaid Services – set up a “Tri-Agency Task Force for Emergency Diagnostics” to rapidly push effective emergency-use tests into the field when outbreaks of Ebola, Zika, Influenza or similar health threats occur in the US or globally.
A novel antibody-based Zika virus assay developed by Humabs Biomed, the NS1 Blockade-of-Binding (BOB) ELISA, can accurately distinguish Zika virus from other viruses, and differentiate it from other flavivirus infections within three hours, according to a recent article in the Proceedings of the National Academy of Sciences. Work to commercially develop the test is just beginning, so the company has not yet submitted it to FDA.