Emerging Tests: New Study Supports Feasibility of At-Home Urine Prostate Cancer Testing
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FDA Unveils New Process for Streamlined Review of IVD Tests Used in Cancer Drug Trials
Typically, in vitro diagnostic (IVDs) tests used in investigational cancer drug trials require two submissions: one for the IVD test and another for the drug. But on Oct. 9, 2019, the US Food and Drug Administration (FDA) issued final guidance setting out a streamlined process that allows companies to apply
Emerging Tests: FDA Issues New Guidance on Using NGS Data to Secure Antiviral Drug & CDx Test Approval
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Industry Buzz: Cologuard’s Wild September Ride
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Emerging Tests: FDA Breaks New Ground by Clearing EIA Technology-Based Lyme Assays
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