Gene amplification test comparison to "gold standard" to be discussed Feb. 11 at joint panel meeting.
This article was originally published in The Gray Sheet
GENE AMPLIFICATION TEST COMPARISON TO "GOLD STANDARD" IN PREMARKET SUBMISSIONS is slated for discussion Feb. 11 at a joint meeting of FDA's four in vitro diagnostics advisory panels. The Microbiology Devices Panel, Clinical Chemistry and Clinical Toxicology Devices Panel, Hematology and Pathology Devices Panel, and Immunology Devices Panel all are gathering at FDA device center offices in Rockville, Maryland to provide input on "how the FDA should proceed" in the area of resolution of discrepant results "when new technology such as nucleic acid amplification is perceived to be more accurate than the reference or "gold standard" methods," according to a recent Federal Register announcement of the meeting.
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