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Top Five Articles on 360Dx Last Week: FDA's New LDT Proposal; Hurdles to POC Routine Testing; More
Last week, readers were most interested in a story about the newest move by the FDA to regulate laboratory-developed tests.
The proposed rule, which is likely to face industry challenges, calls for a four-year phase-in of LDT regulation while also suggesting possible carve-outs.
The test, which detects circulating cell-free DNA in urine samples, may help in reaching World Health Organization elimination goals.
Gene Variant Test Shows Promise for Improving Accuracy of CA19-9 for Pancreatic Cancer Detection
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Investigators are assessing performance in a prospective cohort with hopes that the method can be used to complement currently used imaging surveillance.
FDA Releases Proposed Rule for Oversight of Laboratory-Developed Tests
The rule, which would make explicit FDA's authority to regulate LDTs, is certain to face pushback from many in the laboratory and diagnostics industries.
Sep 25, 2023
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