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Article

Comparing the performance of 2 human papillomavirus assays for a new use indication: a real-world evidence-based evaluation in the United States.

American journal of obstetrics and gynecology - 1 Feb 2024

Wheeler Cosette M, Torrez-Martinez Norah E, Torres-Chavolla Edith, Parvu Valentin, Andrews Jeffrey C, Du Ruofei, Robertson Michael, Joste Nancy E, Cuzick Jack

Abstract excerpt

BACKGROUND: The US Food and Drug Administration supports innovations to facilitate new indications for high-risk human papillomavirus testing. This report describes the retrospective testing of stored specimens and analysis of existing data to efficiently and cost-effectively support a new indication for the Onclarity human papillomavirus assay (Becton, Dickinson and Company, BD Life Sciences - Integrated...

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Identifiers

PMID: 37806613
DOI: 10.1016/j.ajog.2023.09.100

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PubMed metadata and Literature Corpus relationships. Corpus snapshot updated 7 Sept 2026. Manifest publication-graph-cohort-2026-09-07.1.

Source receipt: pubmed, retrieved 7 Sept 2026.

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