FDA Watch: OraSure’s Collection Device for Cobas STI Testing Receives Approval
At-home sample collections can be mailed to a clinical laboratory
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FDA Watch: Zepto Life Technology Receives FDA Breakthrough Designation for Blood-Based Mold Test
Its FungiFlex assay can make determining the cause of fungal infections vastly more accurate
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New Enhancing CLIA Act: What Lab Directors Need to Know
The proposal seeks to move any future LDT authority away from the FDA
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FDA Won’t Release Final LDT Guidance in 2016
From – National Intelligence Report
The U.S. Food and Drug Administration (FDA) has provided laboratories with some much needed good news—the agency will not finalize its…
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CDC and the Diagnostics Industry Continue to Battle Zika
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FDA Recommendation Against Ovarian Cancer Screening
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FDA Considers Liquid Biopsies
From – National Intelligence Report
In addition to laboratory developed tests and next generation sequencing, could the FDA be looking to impose standards or guidance governing use of…
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Public Comment Sought on Blood Donor Deferral Policies to Reduce HIV Transmission
From – National Intelligence Report
While the annual rate of new diagnosed cases has declined in the last 10 years, HIV still remains a significant concern. The Centers for Disease Control and Prevention (CDC) reports…
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FDA Holds Exploratory Meeting on Liquid Biopsies
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FDA Issues Draft Guidelines for Companion Diagnostics
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