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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Culture-Independent Tests Gain Clinical Traction, Hamper Public Health
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U.S. Government Begins Prepping Battle Against Zika with National Summit
From – National Intelligence Report
With spring and mosquito season rapidly approaching, concern about and the fight against the Zika virus is heating up. Today, a press conference will be…
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FDA Challenges DTC Genomic Tests from Startup Labs
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New FDA Approvals, Guidelines and Letters Address Zika Testing
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AACC Weighs in on Regulation of Laboratory Developed Tests
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FDA LDT Regulation Could Affect 60,000+ Tests
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ACLA Uses Cancer Initiative to Lobby on PAMA, LDTs
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Laboratory Data and Interoperability to be Focus of FDA Workshop
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CMS Releases New CLIA-Waived Tests, Billing Codes
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