FDA Watch: Monkeypox, COVID-19, and MDD Tests
While new test approvals were scarce in October, they were particularly impactful; here are three approvals you should know about.
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ACLA: Low Reimbursement Jeopardizes Monkeypox Lab Testing Effort
Medicare Administrative Contractors are shortchanging labs on monkeypox test reimbursement, association says.
Abbott Ushers Monkeypox Testing into Its New Commercial Phase
Abbott has once more gotten the jump by becoming the first company to get EUA clearance for a commercial monkeypox RT-PCR test kit.
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Abbott Scores First FDA Greenlight for Commercial Use of Monkeypox Test
Abbott’s Alinity m MPXV assay for detecting DNA from the monkeypox virus received FDA EUA on Oct. 7.
FDA Reopens EUA & Immediate EUA-Less Use Pipelines for Monkeypox Tests
Despite lessons learned from COVID-19 testing, HHS and FDA plan for monkeypox testing remains flawed.
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