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.
You may also be interested in...
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.
Sanofi will pay $175m up front for rights to commercialize J&J’s potential first-in-class vaccine against E. coli. The two companies will share profits.