Quest Wins First Commercial Zika Test FDA Emergency-Use Approval
This article was originally published in The Gray Sheet
Executive Summary
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...
US FDA Issues Two EUAs For Abbott, ELITechGroup Zika Tests
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.
Don't Finalize LDT Guidance, House Appropriators Tell FDA
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.
US Q1 Consumer Health Earnings Preview: Label This One Historic And Challenging But Promising
US OTC drug and supplement firms’ reports of results for the first three months of 2024 began on April 19 with P&G. JP Morgan analysts say while “some retailers in the US in particular” are reducing consumer health inventories, for the overall sector they expect “a healthier balance of positive volume and lower pricing contribution.”