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 Biological Products Agency Issues New Recommendations for Emergency Weather Response
From – National Intelligence Report
With another hurricane season wreaking havoc, the FDA’s Center for Biologics Evaluation and Research (CBER), which regulates…
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LDTs: FDA Does an End Run on Regulatory Proposal Lab Industry Helped Create
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New Zika Blood Testing Guidance Effective Immediately
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FDA Says LOINC Coding of IVD Tests Is Voluntary, Not Mandatory
From – National Intelligence Report
On June 15, the FDA issued a new guidance document clarifying the rules for laboratory coding of in vitro diagnostic tests. There are four…
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Genomic Tests: Two New Assays Win FDA Breakthrough Device Designation
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New FDA Guidance Aims to Ease Approval for New NGS Tests—But It Probably Won’t Work
From – National Intelligence Report
Test makers have long complained about the FDA’s unwillingness to embrace technology and diagnostics advances. But on April 13, the agency took steps to address…
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Case of the Month: $33.2 Million Alere Settlement Sends Warning Shot Across Bow of LDT & DX Device Makers
From – National Intelligence Report
One of the reasons Abbott Laboratories got cold feet about consummating the $5.3 billion Alere acquisition was concern over the legal proceedings against the…
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FDA Watch: Agency Approves DTC Genetic Breast Cancer Test—But Attaches Strings
From – National Intelligence Report
On March 6, the FDA announced its first ever approval of a direct-to-consumer breast cancer gene test…
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FDA Watch: Extra Time for Comments on CLIA IVD Waiver Proposals
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