Quest Wins First Commercial Zika Test FDA Emergency-Use Approval
This article was originally published in The Gray Sheet
FDA approved the first emergency-use authorization for a commercially developed, molecular-based Zika virus diagnostics, developed by Quest's Focus Diagnostics subsidiary.
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FDA recently issued two Emergency Use Authorizations to two different device firms for their molecular-based Zika virus tests, including for Abbott Molecular's RealTime Zika Assay, and for ELITechGroup's Zika ELITe MGB Kit U.S.
FDA should "suspend further efforts to finalize the laboratory-developed test guidance" and instead work with Congress on a new regulatory pathway for LDTs, House appropriators told the agency in an FY 2017 spending bill, which also adds $10 million to fight the Zika virus.
The company will use the proceeds to fund clinical trials, expand commercialization of its targeted radiation therapy, and file for CE marking in Europe.